Difference between revisions of "Cervical cancer"
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CP+Bev: '''<u>C</u>'''isplatin, '''<u>P</u>'''aclitaxel, '''<u>Bev</u>'''acizumab | CP+Bev: '''<u>C</u>'''isplatin, '''<u>P</u>'''aclitaxel, '''<u>Bev</u>'''acizumab | ||
− | ===Regimen {{#subobject:PYV1|Variant=1}}=== | + | ===Regimen #1, 135 mg/m<sup>2</sup> paclitaxel {{#subobject:PYV1|Variant=1}}=== |
{| border="1" style="text-align:center;" !align="left" | {| border="1" style="text-align:center;" !align="left" | ||
|'''Study''' | |'''Study''' | ||
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|- | |- | ||
|[[#Topotecan_.26_Paclitaxel|Topotecan & Paclitaxel]] | |[[#Topotecan_.26_Paclitaxel|Topotecan & Paclitaxel]] | ||
+ | |style="background-color:#ffffbf"|Seems not superior (*) | ||
+ | |- | ||
+ | |[[#Topotecan.2C_Paclitaxel.2C_Bevacizumab|Topotecan, Paclitaxel, Bevacizumab]] | ||
|style="background-color:#d3d3d3"|Not reported | |style="background-color:#d3d3d3"|Not reported | ||
+ | |- | ||
+ | |} | ||
+ | ''Note: efficacy marked with (*) based on 2017 update.'' | ||
+ | ====Chemotherapy==== | ||
+ | *[[Cisplatin (Platinol)]] 50 mg/m<sup>2</sup> IV once on day 1 | ||
+ | *[[Paclitaxel (Taxol)]] 135 mg/m<sup>2</sup> IV once on day 1 | ||
+ | *[[Bevacizumab (Avastin)]] 15 mg/kg IV once on day 1 | ||
+ | |||
+ | '''21-day cycles; given until progression of disease, unacceptable toxicity, or if the patient had a complete response''' | ||
+ | |||
+ | ===Regimen #2, 175 mg/m<sup>2</sup> paclitaxel {{#subobject:ca025d|Variant=1}}=== | ||
+ | {| border="1" style="text-align:center;" !align="left" | ||
+ | |'''Study''' | ||
+ | |[[Levels_of_Evidence#Evidence|'''Evidence''']] | ||
+ | |'''Comparator''' | ||
+ | |[[Levels_of_Evidence#Efficacy|'''Efficacy''']] | ||
+ | |- | ||
+ | |rowspan=3|[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4010094/ Tewari et al. 2014 (GOG 240)] | ||
+ | |rowspan=3 style="background-color:#00CD00"|Phase III | ||
+ | |[[#Cisplatin_.26_Paclitaxel_2|Cisplatin & Paclitaxel]] | ||
+ | |style="background-color:#91cf60"|Seems to have superior OS | ||
+ | |- | ||
+ | |[[#Topotecan_.26_Paclitaxel|Topotecan & Paclitaxel]] | ||
+ | |style="background-color:#ffffbf"|Seems not superior (*) | ||
|- | |- | ||
|[[#Topotecan.2C_Paclitaxel.2C_Bevacizumab|Topotecan, Paclitaxel, Bevacizumab]] | |[[#Topotecan.2C_Paclitaxel.2C_Bevacizumab|Topotecan, Paclitaxel, Bevacizumab]] | ||
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|- | |- | ||
|} | |} | ||
+ | ''Note: efficacy marked with (*) based on 2017 update.'' | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
*[[Cisplatin (Platinol)]] 50 mg/m<sup>2</sup> IV once on day 1 | *[[Cisplatin (Platinol)]] 50 mg/m<sup>2</sup> IV once on day 1 | ||
− | *[[Paclitaxel (Taxol)]] | + | *[[Paclitaxel (Taxol)]] 175 mg/m<sup>2</sup> IV once on day 1 |
*[[Bevacizumab (Avastin)]] 15 mg/kg IV once on day 1 | *[[Bevacizumab (Avastin)]] 15 mg/kg IV once on day 1 | ||
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===References=== | ===References=== | ||
# Tewari KS, Sill MW, Long HJ 3rd, Penson RT, Huang H, Ramondetta LM, Landrum LM, Oaknin A, Reid TJ, Leitao MM, Michael HE, Monk BJ. Improved survival with bevacizumab in advanced cervical cancer. N Engl J Med. 2014 Feb 20;370(8):734-43. [http://www.nejm.org/doi/full/10.1056/NEJMoa1309748#t=article link to original article] [http://www.nejm.org/doi/suppl/10.1056/NEJMoa1309748/suppl_file/nejmoa1309748_appendix.pdf link to supplementary appendix] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4010094/ link to PMC article] [https://www.ncbi.nlm.nih.gov/pubmed/24552320 PubMed] | # Tewari KS, Sill MW, Long HJ 3rd, Penson RT, Huang H, Ramondetta LM, Landrum LM, Oaknin A, Reid TJ, Leitao MM, Michael HE, Monk BJ. Improved survival with bevacizumab in advanced cervical cancer. N Engl J Med. 2014 Feb 20;370(8):734-43. [http://www.nejm.org/doi/full/10.1056/NEJMoa1309748#t=article link to original article] [http://www.nejm.org/doi/suppl/10.1056/NEJMoa1309748/suppl_file/nejmoa1309748_appendix.pdf link to supplementary appendix] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4010094/ link to PMC article] [https://www.ncbi.nlm.nih.gov/pubmed/24552320 PubMed] | ||
+ | ## '''Update:''' Tewari KS, Sill MW, Penson RT, Huang H, Ramondetta LM, Landrum LM, Oaknin A, Reid TJ, Leitao MM, Michael HE, DiSaia PJ, Copeland LJ, Creasman WT, Stehman FB, Brady MF, Burger RA, Thigpen JT, Birrer MJ, Waggoner SE, Moore DH, Look KY, Koh WJ, Monk BJ. Bevacizumab for advanced cervical cancer: final overall survival and adverse event analysis of a randomised, controlled, open-label, phase 3 trial (Gynecologic Oncology Group 240). Lancet. 2017 Jul 27. [Epub ahead of print] [http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(17)31607-0/fulltext link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/28756902 PubMed] | ||
==Cisplatin & Topotecan {{#subobject:e399c6|Regimen=1}}== | ==Cisplatin & Topotecan {{#subobject:e399c6|Regimen=1}}== |
Revision as of 17:28, 7 October 2017
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48 regimens on this page
66 variants on this page
|
Guidelines
ESMO
NCCN
Chemoradiation
Cisplatin & RT
back to top |
RT: Radiation Therapy
Regimen #1
Study | Evidence | Comparator | Efficacy |
Dueñas-González et al. 2011 | Phase III | Cisplatin, Gemcitabine, RT | Seems to have inferior OS |
Chemoradiotherapy
- Cisplatin (Platinol) 40 mg/m2 IV over 60 minutes once per day on days 1, 8, 15, 22, 29, 36, 1 to 2 hours before radiation
- Concurrent radiation therapy, 1.8 Gy x 28 fractions given 5 days per week, for an initial dose of 50.4 Gy
6-week course, followed by:
Brachytherapy
- Brachytherapy with cesium-137, with 30 to 35 Gy delivered to point A
Regimen #2
Study | Evidence | Comparator | Efficacy |
Lanciano et al. 2005 (GOG 165) | Phase III | Fluorouracil & RT | Might have superior ORR |
Chemoradiotherapy
- Cisplatin (Platinol) 40 mg/m2 (maximum of 70 mg per dose) IV once per day on days 1, 8, 15, 22, 29, 36, 4 hours before radiation
- Concurrent radiation therapy, 1.8 Gy x 25 fractions, for an initial dose of 40.8 Gy
Brachytherapy
- EITHER Low-dose rate intracavitary brachytherapy of 40 Gy to point A given in 1 to 2 fractions
- OR High-dose rate intracavitary brachytherapy of 30 Gy to point A given in 5 fractions, starting week 4 of XRT
- Parametrial boost of 5.4 to 9 Gy was administered to the involved parametrium after whole pelvic RT was complete
Regimen #3
Study | Evidence | Comparator | Efficacy |
Rose et al. 1999 (GOG 120) | Phase III | Cisplatin, Fluorouracil, Hydroxyurea, RT | Seems not superior |
Hydroxyurea & RT | Superior OS |
Chemoradiotherapy
- Cisplatin (Platinol) 40 mg/m2 IV over 60 minutes once per day on days 1, 8, 15, 22, 29, 36, 4 hours before radiation
- Concurrent radiation therapy
- Stage IIB patients received 1.7 Gy x 24 fractions, for an initial dose of 40.8 Gy
- Stage III or IVA disease received 1.7 Gy x 30 fractions, for an initial dose of 51 Gy
6-week course, followed in 1 to 3 weeks by:
Brachytherapy
- Stage IIB patients received 40 Gy by intracavitary brachytherapy, for a total dose of 80.8 Gy to point A
- Stage III or IVA disease received 30 Gy by intracavitary brachytherapy, for a total dose of 81 Gy to point A
- Patients that could not receive brachytherapy underwent additional external beam radiation therapy for a total dose of 61.2 Gy
References
- Rose PG, Bundy BN, Watkins EB, Thigpen JT, Deppe G, Maiman MA, Clarke-Pearson DL, Insalaco S. Concurrent cisplatin-based radiotherapy and chemotherapy for locally advanced cervical cancer. N Engl J Med. 1999 Apr 15;340(15):1144-53. link to original article contains verified protocol PubMed
- Update: Rose PG, Ali S, Watkins E, Thigpen JT, Deppe G, Clarke-Pearson DL, Insalaco S; Gynecologic Oncology Group. Long-term follow-up of a randomized trial comparing concurrent single agent cisplatin, cisplatin-based combination chemotherapy, or hydroxyurea during pelvic irradiation for locally advanced cervical cancer: a Gynecologic Oncology Group Study. J Clin Oncol. 2007 Jul 1;25(19):2804-10. Epub 2007 May 14. link to original article PubMed
- Lanciano R, Calkins A, Bundy BN, Parham G, Lucci JA 3rd, Moore DH, Monk BJ, O'Connor DM. Randomized comparison of weekly cisplatin or protracted venous infusion of fluorouracil in combination with pelvic radiation in advanced cervix cancer: a gynecologic oncology group study. J Clin Oncol. 2005 Nov 20;23(33):8289-95. Epub 2005 Oct 17. link to original article contains verified protocol PubMed
- Dueñas-González A, Zarbá JJ, Patel F, Alcedo JC, Beslija S, Casanova L, Pattaranutaporn P, Hameed S, Blair JM, Barraclough H, Orlando M. Phase III, open-label, randomized study comparing concurrent gemcitabine plus cisplatin and radiation followed by adjuvant gemcitabine and cisplatin versus concurrent cisplatin and radiation in patients with stage IIB to IVA carcinoma of the cervix. J Clin Oncol. 2011 May 1;29(13):1678-85. Epub 2011 Mar 28. link to original article contains verified protocol PubMed
- Lutgens LC, Koper PC, Jobsen JJ, van der Steen-Banasik EM, Creutzberg CL, van den Berg HA, Ottevanger PB, van Rhoon GC, van Doorn HC, Houben R, van der Zee J. Radiation therapy combined with hyperthermia versus cisplatin for locally advanced cervical cancer: Results of the randomized RADCHOC trial. Radiother Oncol. 2016 Sep;120(3):378-382. Epub 2016 Feb 17. PubMed
Cisplatin & RT -> Hysterectomy
back to top |
RT: Radiation Therapy
Regimen
Study | Evidence | Comparator | Efficacy |
Keys et al. 1999 (GOG 123) | Phase III | RT -> Hysterectomy | Superior OS |
Chemoradiation
- Cisplatin (Platinol) 40 mg/m2 (maximum of 70 mg per dose) IV once per day on days 1, 8, 15, 22, 29, 36, 4 hours before radiation
- Concurrent radiation therapy, 1.8 to 2 Gy given 5 days per week, for an initial dose of 45 Gy
- After external beam radiation, low-dose brachytherapy was administered, with 30 Gy to point A for a total dose of 75 Gy
All patients proceeded to adjuvant hysterectomy.
References
- Keys HM, Bundy BN, Stehman FB, Muderspach LI, Chafe WE, Suggs CL 3rd, Walker JL, Gersell D. Cisplatin, radiation, and adjuvant hysterectomy compared with radiation and adjuvant hysterectomy for bulky stage IB cervical carcinoma. N Engl J Med. 1999 Apr 15;340(15):1154-61. link to original article contains verified protocol PubMed
Cisplatin, Fluorouracil, RT
back to top |
RT: Radiation Therapy
Regimen
Study | Evidence | Comparator | Efficacy |
Whitney et al. 1999 (GOG 85/SWOG 8695) | Phase III | Hydroxyurea & RT | Seems to have superior OS |
Peters et al. 2000 (GOG 109/SWOG-8797) | Phase III | Radiation therapy | Superior OS |
Chemotherapy
- Cisplatin (Platinol) 70 mg/m2 IV over 2 hours once on day 1
- Fluorouracil (5-FU) 1000 mg/m2/day IV continuous infusion over 96 hours on days 1 to 4 (total dose: 4000 mg/m2)
21-day cycle for 4 cycles
Concurrent radiation therapy
- Concurrent radiation therapy, 1.7 Gy x 29 fractions given 5 days per week, for a total dose of 49.3 Gy
- Patients with positive high common iliac lymph nodes also received 1.5 Gy x 30 fractions given 5 days per week, for a total dose of 45 Gy
6-week course, started on cycle 1 day 1
References
- Whitney CW, Sause W, Bundy BN, Malfetano JH, Hannigan EV, Fowler WC Jr, Clarke-Pearson DL, Liao SY. Randomized comparison of fluorouracil plus cisplatin versus hydroxyurea as an adjunct to radiation therapy in stage IIB-IVA carcinoma of the cervix with negative para-aortic lymph nodes: a Gynecologic Oncology Group and Southwest Oncology Group study. J Clin Oncol. 1999 May;17(5):1339-48. link to original article PubMed
- Peters WA 3rd, Liu PY, Barrett RJ 2nd, Stock RJ, Monk BJ, Berek JS, Souhami L, Grigsby P, Gordon W Jr, Alberts DS. Concurrent chemotherapy and pelvic radiation therapy compared with pelvic radiation therapy alone as adjuvant therapy after radical surgery in high-risk early-stage cancer of the cervix. J Clin Oncol. 2000 Apr;18(8):1606-13. link to original article contains verified protocol PubMed
Cisplatin, Fluorouracil, Hydroxyurea, RT
back to top |
RT: Radiation Therapy
Regimen
Study | Evidence | Comparator | Efficacy |
Rose et al. 1999 (GOG 120) | Phase III | Cisplatin & RT | Seems not superior |
Hydroxyurea & RT | Superior OS |
Chemoradiotherapy
- Cisplatin (Platinol) 50 mg/m2 IV once per day on days 1 & 29
- Fluorouracil (5-FU) 1000 mg/m2/day IV continuous infusion over 96 hours on days 1 to 4, 29 to 32 (total dose: 8000 mg/m2)
- Hydroxyurea (Hydrea) 2000 mg/m2 PO two times per week, 2 hours before radiation on weeks 1 to 6
- Concurrent radiation therapy
- Stage IIB patients received 1.7 Gy x 24 fractions, for an initial dose of 40.8 Gy
- Stage III or IVA disease received 1.7 Gy x 30 fractions, for an initial dose of 51 Gy
6-week course, followed in 1 to 3 weeks by:
Brachytherapy
- Stage IIB patients received 40 Gy by intracavitary brachytherapy, for a total dose of 80.8 Gy to point A
- Stage III or IVA disease received 30 Gy by intracavitary brachytherapy, for a total dose of 81 Gy to point A
- Patients that could not receive brachytherapy underwent additional external beam radiation therapy for a total dose of 61.2 Gy
References
- Rose PG, Bundy BN, Watkins EB, Thigpen JT, Deppe G, Maiman MA, Clarke-Pearson DL, Insalaco S. Concurrent cisplatin-based radiotherapy and chemotherapy for locally advanced cervical cancer. N Engl J Med. 1999 Apr 15;340(15):1144-53. link to original article contains verified protocol PubMed
- Update: Rose PG, Ali S, Watkins E, Thigpen JT, Deppe G, Clarke-Pearson DL, Insalaco S; Gynecologic Oncology Group. Long-term follow-up of a randomized trial comparing concurrent single agent cisplatin, cisplatin-based combination chemotherapy, or hydroxyurea during pelvic irradiation for locally advanced cervical cancer: a Gynecologic Oncology Group Study. J Clin Oncol. 2007 Jul 1;25(19):2804-10. Epub 2007 May 14. link to original article PubMed
Cisplatin, Gemcitabine, RT
back to top |
RT: Radiation Therapy
Regimen
Study | Evidence | Comparator | Efficacy |
Dueñas-González et al. 2011 | Phase III | Cisplatin & RT | Seems to have superior OS |
Chemoradiotherapy
- Cisplatin (Platinol) 40 mg/m2 IV over 60 minutes once per day on days 1, 8, 15, 22, 29, 36, given first, 1 to 2 hours before radiation
- Gemcitabine (Gemzar) 125 mg/m2 IV over 30 to 60 minutes once per day on days 1, 8, 15, 22, 29, 36, given second, 1 to 2 hours before radiation
- Concurrent radiation therapy, 1.8 Gy x 28 fractions given 5 days per week, for an initial dose of 50.4 Gy
6-week course, followed by:
Brachytherapy
- Brachytherapy with cesium-137, with 30-35 Gy delivered to point A
Followed in 2 weeks by:
Chemotherapy
- Cisplatin (Platinol) 50 mg/m2 IV once on day 1
- Gemcitabine (Gemzar) 1000 mg/m2 IV once per day on days 1 & 8
21-day cycle for 2 cycles
References
- Dueñas-González A, Zarbá JJ, Patel F, Alcedo JC, Beslija S, Casanova L, Pattaranutaporn P, Hameed S, Blair JM, Barraclough H, Orlando M. Phase III, open-label, randomized study comparing concurrent gemcitabine plus cisplatin and radiation followed by adjuvant gemcitabine and cisplatin versus concurrent cisplatin and radiation in patients with stage IIB to IVA carcinoma of the cervix. J Clin Oncol. 2011 May 1;29(13):1678-85. Epub 2011 Mar 28. link to original article contains verified protocol PubMed
Fluorouracil & RT
back to top |
RT: Radiation Therapy
Regimen
Study | Evidence | Comparator | Efficacy |
Lanciano et al. 2005 (GOG 165) | Phase III | Cisplatin & RT | Might have inferior ORR |
Chemoradiotherapy
- Fluorouracil (5-FU) 225 mg/m2/day IV continuous infusion over five days per week x 6 weeks (total dose: 6750 mg/m2)
- Concurrent radiation therapy, 1.8 Gy x 25 fractions, for an initial dose of 40.8 Gy
- Brachytherapy involved:
- EITHER Low-dose rate intracavitary brachytherapy of 40 Gy to point A given in 1 to 2 fractions
- OR High-dose rate intracavitary brachytherapy of 30 Gy to point A given in 5 fractions, starting week 4 of XRT
- Parametrial boost of 5.4 to 9 Gy was administered to the involved parametrium after whole pelvic RT was complete
References
- Lanciano R, Calkins A, Bundy BN, Parham G, Lucci JA 3rd, Moore DH, Monk BJ, O'Connor DM. Randomized comparison of weekly cisplatin or protracted venous infusion of fluorouracil in combination with pelvic radiation in advanced cervix cancer: a gynecologic oncology group study. J Clin Oncol. 2005 Nov 20;23(33):8289-95. Epub 2005 Oct 17. link to original article contains verified protocol PubMed
Hydroxyurea & RT
back to top |
RT: Radiation Therapy
Regimen
Study | Evidence | Comparator | Efficacy |
Hreshchyshyn et al. 1979 (GOG 04) | Phase III | Radiation therapy | Seems to have superior OS |
Rose et al. 1999 (GOG 120) | Phase III | Cisplatin & RT | Inferior OS |
Cisplatin, Fluorouracil, Hydroxyurea, RT | Inferior OS | ||
Whitney et al. 1999 (GOG 85/SWOG 8695) | Phase III | Cisplatin, Fluorouracil, RT | Seems to have inferior OS |
Chemoradiotherapy
- Hydroxyurea (Hydrea) 2000 mg/m2 PO two times per week, 2 hours before radiation on weeks 1 to 6
- Concurrent radiation therapy as follows:
- Stage IIB patients received 1.7 Gy x 24 fractions, for an initial dose of 40.8 Gy
- Stage III or IVA disease received 1.7 Gy x 30 fractions, for an initial dose of 51 Gy
6-week course, followed in 1 to 3 weeks by:
Brachytherapy
- Stage IIB patients received 40 Gy by intracavitary brachytherapy, for a total dose of 80.8 Gy to point A
- Stage III or IVA disease received 30 Gy by intracavitary brachytherapy, for a total dose of 81 Gy to point A
- Patients that could not receive brachytherapy underwent additional external beam radiation therapy for a total dose of 61.2 Gy
References
- Hreshchyshyn MM, Aron BS, Boronow RC, Franklin EW 3rd, Shingleton HM, Blessing JA. Hydroxyurea or placebo combined with radiation to treat stages IIIB and IV cervical cancer confined to the pelvis. Int J Radiat Oncol Biol Phys. 1979 Mar;5(3):317-22. link to original article PubMed
- Rose PG, Bundy BN, Watkins EB, Thigpen JT, Deppe G, Maiman MA, Clarke-Pearson DL, Insalaco S. Concurrent cisplatin-based radiotherapy and chemotherapy for locally advanced cervical cancer. N Engl J Med. 1999 Apr 15;340(15):1144-53. link to original article contains verified protocol PubMed
- Update: Rose PG, Ali S, Watkins E, Thigpen JT, Deppe G, Clarke-Pearson DL, Insalaco S; Gynecologic Oncology Group. Long-term follow-up of a randomized trial comparing concurrent single agent cisplatin, cisplatin-based combination chemotherapy, or hydroxyurea during pelvic irradiation for locally advanced cervical cancer: a Gynecologic Oncology Group Study. J Clin Oncol. 2007 Jul 1;25(19):2804-10. Epub 2007 May 14. link to original article PubMed
- Whitney CW, Sause W, Bundy BN, Malfetano JH, Hannigan EV, Fowler WC Jr, Clarke-Pearson DL, Liao SY. Randomized comparison of fluorouracil plus cisplatin versus hydroxyurea as an adjunct to radiation therapy in stage IIB-IVA carcinoma of the cervix with negative para-aortic lymph nodes: a Gynecologic Oncology Group and Southwest Oncology Group study. J Clin Oncol. 1999 May;17(5):1339-48. link to original article PubMed
Radiation therapy
back to top |
Regimen
Study | Evidence | Comparator | Efficacy |
Peters et al. 2000 (GOG 109/SWOG-8797) | Phase III | Cisplatin, Fluorouracil, RT | Inferior OS |
Demonstrably inferior; here for reference purposes only.
References
- Peters WA 3rd, Liu PY, Barrett RJ 2nd, Stock RJ, Monk BJ, Berek JS, Souhami L, Grigsby P, Gordon W Jr, Alberts DS. Concurrent chemotherapy and pelvic radiation therapy compared with pelvic radiation therapy alone as adjuvant therapy after radical surgery in high-risk early-stage cancer of the cervix. J Clin Oncol. 2000 Apr;18(8):1606-13. link to original article contains verified protocol PubMed
RT -> Hysterectomy
back to top |
RT: Radiation Therapy
Regimen
Study | Evidence | Comparator | Efficacy |
Hreshchyshyn et al. 1979 (GOG 04) | Phase III | Hydroxyurea & RT | Seems to have inferior OS |
Keys et al. 1999 (GOG 123) | Phase III | Cisplatin & RT -> Hysterectomy | Inferior OS |
Demonstrably inferior; here for reference purposes only.
References
- Hreshchyshyn MM, Aron BS, Boronow RC, Franklin EW 3rd, Shingleton HM, Blessing JA. Hydroxyurea or placebo combined with radiation to treat stages IIIB and IV cervical cancer confined to the pelvis. Int J Radiat Oncol Biol Phys. 1979 Mar;5(3):317-22. link to original article PubMed
- Keys HM, Bundy BN, Stehman FB, Muderspach LI, Chafe WE, Suggs CL 3rd, Walker JL, Gersell D. Cisplatin, radiation, and adjuvant hysterectomy compared with radiation and adjuvant hysterectomy for bulky stage IB cervical carcinoma. N Engl J Med. 1999 Apr 15;340(15):1154-61. link to original article contains verified protocol PubMed
Neoadjuvant chemotherapy
Cisplatin & Paclitaxel
back to top |
Regimen
Study | Evidence |
Park et al. 2004 | Phase II |
Chemotherapy
- Cisplatin (Platinol) 60 mg/m2 IV over 2 hours once on day 1, given second
- Paclitaxel (Taxol) 60 mg/m2 IV over 3 hours once on day 1, given first
Supportive medications
- Dexamethasone (Decadron) 20 mg PO 12 and 6 hours before Paclitaxel (Taxol)
- Cimetidine (Tagamet) 300 mg IV 30 minutes prior to Paclitaxel (Taxol)
- Diphenhydramine (Benadryl) 50 mg IV 30 minutes prior to Paclitaxel (Taxol)
- Antiemetics before and 3 days after chemotherapy
10-day cycle for 3 cycles
Clinical response assessed after 3 cycles with pelvic examination and MRI.
References
- Park DC, Kim JH, Lew YO, Kim DH, Namkoong SE. Phase II trial of neoadjuvant paclitaxel and cisplatin in uterine cervical cancer. Gynecol Oncol. 2004 Jan;92(1):59-63. link to original article contains verified protocol PubMed
Locally Advanced or Metastatic disease
Bevacizumab monotherapy
back to top |
Regimen
Study | Evidence |
Monk et al. 2009 (GOG 227-C) | Phase II |
Chemotherapy
- Bevacizumab (Avastin) 15 mg/kg IV once on day 1
21-day cycles
References
- Monk BJ, Sill MW, Burger RA, Gray HJ, Buekers TE, Roman LD. Phase II trial of bevacizumab in the treatment of persistent or recurrent squamous cell carcinoma of the cervix: a gynecologic oncology group study. J Clin Oncol. 2009 Mar 1;27(7):1069-74. Epub 2009 Jan 12. link to original article contains verified protocol link to PMC article PubMed
Carboplatin monotherapy
back to top |
Regimen
Study | Evidence |
Weiss et al. 1990 | Phase II |
Chemotherapy
- Carboplatin (Paraplatin) 400 mg/m2 IV once on day 1
28-day cycles
References
- Weiss GR, Green S, Hannigan EV, Boutselis JG, Surwit EA, Wallace DL, Alberts DS. A phase II trial of carboplatin for recurrent or metastatic squamous carcinoma of the uterine cervix: a Southwest Oncology Group study. Gynecol Oncol. 1990 Dec;39(3):332-6. link to original article PubMed
Carboplatin & Docetaxel
back to top |
Regimen
Study | Evidence |
Nagao et al. 2005 | Phase II |
Chemotherapy
- Carboplatin (Paraplatin) AUC 6 IV over 1 hour on day 1, given second
- Docetaxel (Taxotere) 60 mg/m2 IV over 1 hour on day 1, given first
Supportive medications
- Dexamethasone (Decadron)
- Ondansetron (Zofran) or Granisetron (Kytril) for antiemesis
- Filgrastim (Neupogen) 5 mcg/kg once per day for patients with grade 4 neutropenia or febrile neutropenia
21-day cycles
References
- Nagao S, Fujiwara K, Oda T, Ishikawa H, Koike H, Tanaka H, Kohno I. Combination chemotherapy of docetaxel and carboplatin in advanced or recurrent cervix cancer. A pilot study. Gynecol Oncol. 2005 Mar;96(3):805-9. link to original article contains verified protocol PubMed
- Takekida S, Fujiwara K, Nagao S, Yamaguchi S, Yoshida N, Kitada F, Kigawa J, Terakawa N, Nishimura R. Phase II study of combination chemotherapy with docetaxel and carboplatin for locally advanced or recurrent cervical cancer. Int J Gynecol Cancer. 2010 Dec;20(9):1563-8. PubMed
Carboplatin & Paclitaxel
back to top |
Regimen
Study | Evidence |
Pectasides et al. 2009 | Phase II |
Chemotherapy
- Carboplatin (Paraplatin) AUC 5 IV over 1 hour once on day 1
- Paclitaxel (Taxol) 175 mg/m2 IV over 3 hours once on day 1
21-day cycle for 6 to 9 cycles
References
- Pectasides D, Fountzilas G, Papaxoinis G, Pectasides E, Xiros N, Sykiotis C, Koumarianou A, Psyrri A, Panayiotides J, Economopoulos T. Carboplatin and paclitaxel in metastatic or recurrent cervical cancer. Int J Gynecol Cancer. 2009 May;19(4):777-81. link to original article contains protocol PubMed
Cisplatin monotherapy
back to top |
Regimen
Study | Evidence | Comparator | Efficacy |
Moore et al. 2004 (GOG-169) | Phase III | Cisplatin & Paclitaxel | Inferior PFS |
Long et al. 2005 | Phase III | Cisplatin & Topotecan | Seems to have inferior OS |
MVAC | Not reported |
Chemotherapy
- Cisplatin (Platinol) 50 mg/m2 IV once on day 1
21-day cycles; if not responding, given for maximum of 6 cycles
References
- Moore DH, Blessing JA, McQuellon RP, Thaler HT, Cella D, Benda J, Miller DS, Olt G, King S, Boggess JF, Rocereto TF. Phase III study of cisplatin with or without paclitaxel in stage IVB, recurrent, or persistent squamous cell carcinoma of the cervix: a gynecologic oncology group study. J Clin Oncol. 2004 Aug 1;22(15):3113-9. link to original article contains verified protocol PubMed
- Long HJ 3rd, Bundy BN, Grendys EC Jr, Benda JA, McMeekin DS, Sorosky J, Miller DS, Eaton LA, Fiorica JV; Gynecologic Oncology Group Study. Randomized phase III trial of cisplatin with or without topotecan in carcinoma of the uterine cervix: a Gynecologic Oncology Group Study. J Clin Oncol. 2005 Jul 20;23(21):4626-33. Epub 2005 May 23. link to original article contains verified protocol PubMed
Cisplatin & Gemcitabine
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GC: Gemcitabine, Cisplatin
Regimen #1, 3-week cycles
Study | Evidence | Comparator | Efficacy |
Monk et al. 2009 | Phase III | Cisplatin & Paclitaxel | Seems to have inferior PFS |
Cisplatin & Topotecan | Seems not superior | ||
Cisplatin & Vinorelbine | Seems not superior |
Chemotherapy
- Cisplatin (Platinol) 50 mg/m2 IV once on day 1
- Gemcitabine (Gemzar) 1000 mg/m2 IV once per day on days 1 & 8
21-day cycles
Regimen #2, 4-week cycles
Study | Evidence |
Brewer et al. 2006 | Phase II |
Chemotherapy
- Cisplatin (Platinol) 30 mg/m2 IV once on day 1, given first
- Gemcitabine (Gemzar) 800 mg/m2 IV once per day on days 1 & 8, given second
28-day cycles
References
- Brewer CA, Blessing JA, Nagourney RA, McMeekin DS, Lele S, Zweizig SL. Cisplatin plus gemcitabine in previously treated squamous cell carcinoma of the cervix: a phase II study of the Gynecologic Oncology Group. Gynecol Oncol. 2006 Feb;100(2):385-8. Epub 2005 Nov 4. link to original article contains verified protocol PubMed
- Monk BJ, Sill MW, McMeekin DS, Cohn DE, Ramondetta LM, Boardman CH, Benda J, Cella D. Phase III trial of four cisplatin-containing doublet combinations in stage IVB, recurrent, or persistent cervical carcinoma: a Gynecologic Oncology Group study. J Clin Oncol. 2009 Oct 1;27(28):4649-55. Epub 2009 Aug 31. link to original article contains verified protocol link to PMC article PubMed
Cisplatin & Mitomycin
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Regimen
Study | Evidence | ORR |
Wagenaar et al. 2001 | Phase II | 42% (95% CI: 26-61%) |
Chemotherapy
- Cisplatin (Platinol) 50 mg/m2 IV once on day 1, given second
- Mitomycin (Mutamycin) 6 mg/m2 IV push on day 1, given first
Supportive medications
- 1 liter NS over 1 hour before chemotherapy, and 1 liter NS over 1 hour after Cisplatin (Platinol)
- Furosemide (Lasix) prior to chemotherapy
- Mannitol IV push prior to Cisplatin (Platinol)
28-day cycle for 9 cycles
References
- Wagenaar HC, Pecorelli S, Mangioni C, van der Burg ME, Rotmensz N, Anastasopoulou A, Zola P, Veenhof CH, Lacave AJ, Neijt JP, van Oosterom AT, Einhorn N, Vermorken JB. Phase II study of mitomycin-C and cisplatin in disseminated, squamous cell carcinoma of the uterine cervix. A European Organization for Research and Treatment of Cancer (EORTC) Gynecological Cancer Group study. Eur J Cancer. 2001 Sep;37(13):1624-8. link to original article contains verified protocol PubMed
Cisplatin & Paclitaxel
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PC: Paclitaxel, Cisplatin
CP: Cisplatin, Paclitaxel
Regimen #1, 135 mg/m2 paclitaxel
Study | Evidence | Comparator | Efficacy |
Tewari et al. 2014 (GOG 240) | Phase III | Cisplatin, Paclitaxel, Bevacizumab | Seems to have inferior OS |
Topotecan & Paclitaxel | Seems not superior | ||
Topotecan, Paclitaxel, Bevacizumab | Not reported |
Chemotherapy
- Cisplatin (Platinol) 50 mg/m2 IV once on day 1
- Paclitaxel (Taxol) 135 mg/m2 IV once on day 1
21-day cycles, given until progression of disease, unacceptable toxicity, or if the patient had a complete response
Regimen #2, 175 mg/m2 paclitaxel
Study | Evidence | Comparator | Efficacy |
Tewari et al. 2014 (GOG 240) | Phase III | Cisplatin, Paclitaxel, Bevacizumab | Seems to have inferior OS |
Topotecan & Paclitaxel | Seems not superior | ||
Topotecan, Paclitaxel, Bevacizumab | Not reported |
Chemotherapy
- Cisplatin (Platinol) 50 mg/m2 IV once on day 1
- Paclitaxel (Taxol) 175 mg/m2 IV once on day 1
21-day cycles, given until progression of disease, unacceptable toxicity, or if the patient had a complete response
Regimen #3, CI paclitaxel
Study | Evidence | Comparator | Efficacy |
Moore et al. 2004 (GOG-169) | Phase III | Cisplatin | Superior PFS |
Monk et al. 2009 | Phase III | Cisplatin & Gemcitabine | Seems to have superior PFS |
Cisplatin & Topotecan | Seems not superior | ||
Cisplatin & Vinorelbine | Might have superior PFS |
Chemotherapy
- Cisplatin (Platinol) 50 mg/m2 IV once on day 2
- Paclitaxel (Taxol) 135 mg/m2 IV continuous infusion over 24 hours on day 1
Supportive medications
- (varies depending on reference):
- Dexamethasone (Decadron), Diphenhydramine (Benadryl), H2 receptor antagonist (such as Cimetidine (Tagamet) or Ranitidine (Zantac)), and prophylactic antiemetics.
- "Adequate IV hydration and electrolyte replacement"
21-day cycles; if not responding, given for maximum of 6 cycles.
References
- Moore DH, Blessing JA, McQuellon RP, Thaler HT, Cella D, Benda J, Miller DS, Olt G, King S, Boggess JF, Rocereto TF. Phase III study of cisplatin with or without paclitaxel in stage IVB, recurrent, or persistent squamous cell carcinoma of the cervix: a gynecologic oncology group study. J Clin Oncol. 2004 Aug 1;22(15):3113-9. link to original article contains verified protocol PubMed
- Monk BJ, Sill MW, McMeekin DS, Cohn DE, Ramondetta LM, Boardman CH, Benda J, Cella D. Phase III trial of four cisplatin-containing doublet combinations in stage IVB, recurrent, or persistent cervical carcinoma: a Gynecologic Oncology Group study. J Clin Oncol. 2009 Oct 1;27(28):4649-55. Epub 2009 Aug 31. link to original article contains verified protocol link to PMC article PubMed
- Tewari KS, Sill MW, Long HJ 3rd, Penson RT, Huang H, Ramondetta LM, Landrum LM, Oaknin A, Reid TJ, Leitao MM, Michael HE, Monk BJ. Improved survival with bevacizumab in advanced cervical cancer. N Engl J Med. 2014 Feb 20;370(8):734-43. link to original article link to supplementary appendix contains verified protocol link to PMC article PubMed
- Update: Tewari KS, Sill MW, Penson RT, Huang H, Ramondetta LM, Landrum LM, Oaknin A, Reid TJ, Leitao MM, Michael HE, DiSaia PJ, Copeland LJ, Creasman WT, Stehman FB, Brady MF, Burger RA, Thigpen JT, Birrer MJ, Waggoner SE, Moore DH, Look KY, Koh WJ, Monk BJ. Bevacizumab for advanced cervical cancer: final overall survival and adverse event analysis of a randomised, controlled, open-label, phase 3 trial (Gynecologic Oncology Group 240). Lancet. 2017 Jul 27. [Epub ahead of print] link to original article PubMed
Cisplatin, Paclitaxel, Bevacizumab
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CP+Bev: Cisplatin, Paclitaxel, Bevacizumab
Regimen #1, 135 mg/m2 paclitaxel
Study | Evidence | Comparator | Efficacy |
Tewari et al. 2014 (GOG 240) | Phase III | Cisplatin & Paclitaxel | Seems to have superior OS |
Topotecan & Paclitaxel | Seems not superior (*) | ||
Topotecan, Paclitaxel, Bevacizumab | Not reported |
Note: efficacy marked with (*) based on 2017 update.
Chemotherapy
- Cisplatin (Platinol) 50 mg/m2 IV once on day 1
- Paclitaxel (Taxol) 135 mg/m2 IV once on day 1
- Bevacizumab (Avastin) 15 mg/kg IV once on day 1
21-day cycles; given until progression of disease, unacceptable toxicity, or if the patient had a complete response
Regimen #2, 175 mg/m2 paclitaxel
Study | Evidence | Comparator | Efficacy |
Tewari et al. 2014 (GOG 240) | Phase III | Cisplatin & Paclitaxel | Seems to have superior OS |
Topotecan & Paclitaxel | Seems not superior (*) | ||
Topotecan, Paclitaxel, Bevacizumab | Not reported |
Note: efficacy marked with (*) based on 2017 update.
Chemotherapy
- Cisplatin (Platinol) 50 mg/m2 IV once on day 1
- Paclitaxel (Taxol) 175 mg/m2 IV once on day 1
- Bevacizumab (Avastin) 15 mg/kg IV once on day 1
21-day cycles; given until progression of disease, unacceptable toxicity, or if the patient had a complete response
References
- Tewari KS, Sill MW, Long HJ 3rd, Penson RT, Huang H, Ramondetta LM, Landrum LM, Oaknin A, Reid TJ, Leitao MM, Michael HE, Monk BJ. Improved survival with bevacizumab in advanced cervical cancer. N Engl J Med. 2014 Feb 20;370(8):734-43. link to original article link to supplementary appendix contains verified protocol link to PMC article PubMed
- Update: Tewari KS, Sill MW, Penson RT, Huang H, Ramondetta LM, Landrum LM, Oaknin A, Reid TJ, Leitao MM, Michael HE, DiSaia PJ, Copeland LJ, Creasman WT, Stehman FB, Brady MF, Burger RA, Thigpen JT, Birrer MJ, Waggoner SE, Moore DH, Look KY, Koh WJ, Monk BJ. Bevacizumab for advanced cervical cancer: final overall survival and adverse event analysis of a randomised, controlled, open-label, phase 3 trial (Gynecologic Oncology Group 240). Lancet. 2017 Jul 27. [Epub ahead of print] link to original article PubMed
Cisplatin & Topotecan
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TC: Topotecan, Cisplatin
Regimen
Study | Evidence | Comparator | Efficacy |
Long et al. 2005 | Phase III | Cisplatin | Seems to have superior OS |
MVAC | Not reported | ||
Monk et al. 2009 | Phase III | Cisplatin & Gemcitabine | Seems not superior |
Cisplatin & Paclitaxel | Seems not superior | ||
Cisplatin & Vinorelbine | Seems not superior |
Chemotherapy
- Cisplatin (Platinol) 50 mg/m2 IV once on day 1, given second
- Topotecan (Hycamtin) 0.75 mg/m2 IV over 30 minutes once per day on days 1 to 3, given first
21-day cycles; if not responding, given for maximum of 6 cycles
References
- Long HJ 3rd, Bundy BN, Grendys EC Jr, Benda JA, McMeekin DS, Sorosky J, Miller DS, Eaton LA, Fiorica JV; Gynecologic Oncology Group Study. Randomized phase III trial of cisplatin with or without topotecan in carcinoma of the uterine cervix: a Gynecologic Oncology Group Study. J Clin Oncol. 2005 Jul 20;23(21):4626-33. Epub 2005 May 23. link to original article contains verified protocol PubMed
- Monk BJ, Sill MW, McMeekin DS, Cohn DE, Ramondetta LM, Boardman CH, Benda J, Cella D. Phase III trial of four cisplatin-containing doublet combinations in stage IVB, recurrent, or persistent cervical carcinoma: a Gynecologic Oncology Group study. J Clin Oncol. 2009 Oct 1;27(28):4649-55. Epub 2009 Aug 31. link to original article contains verified protocol link to PMC article PubMed
Cisplatin & Vinorelbine
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VC: Vinorelbine, Cisplatin
Regimen
Study | Evidence | Comparator | Efficacy |
Monk et al. 2009 | Phase III | Cisplatin & Gemcitabine | Seems not superior |
Cisplatin & Paclitaxel | Might have inferior PFS | ||
Cisplatin & Topotecan | Seems not superior |
Chemotherapy
- Cisplatin (Platinol) 50 mg/m2 IV once on day 1
- Vinorelbine (Navelbine) 30 mg/m2 IV once per day on days 1 & 8
21-day cycles; if not responding, given for maximum of 6 cycles
References
- Monk BJ, Sill MW, McMeekin DS, Cohn DE, Ramondetta LM, Boardman CH, Benda J, Cella D. Phase III trial of four cisplatin-containing doublet combinations in stage IVB, recurrent, or persistent cervical carcinoma: a Gynecologic Oncology Group study. J Clin Oncol. 2009 Oct 1;27(28):4649-55. Epub 2009 Aug 31. link to original article contains verified protocol link to PMC article PubMed
Docetaxel monotherapy
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Regimen #1, 4-week cycles
Study | Evidence |
Garcia et al. 2008 | Phase II |
Chemotherapy
- Docetaxel (Taxotere) 36 mg/m2 IV over 1 hour once per day on days 1, 8, 15
Supportive medications
- Dexamethasone (Decadron) 8 mg PO the evening before, morning of, and evening of each dose of docetaxel
28-day cycles
Regimen #2, 3-week cycles
Study | Evidence |
Garcia et al. 2007 | Phase II |
Chemotherapy
- Docetaxel (Taxotere) 100 mg/m2 IV over 1 hour once on day 1
21-day cycles
References
- Garcia AA, Blessing JA, Vaccarello L, Roman LD; Gynecologic Oncology Group Study. Phase II clinical trial of docetaxel in refractory squamous cell carcinoma of the cervix: a Gynecologic Oncology Group Study. Am J Clin Oncol. 2007 Aug;30(4):428-31. link to original article contains protocol PubMed
- Garcia AA, Blessing JA, Nolte S, Mannel RS; Gynecologic Oncology Group. A phase II evaluation of weekly docetaxel in the treatment of recurrent or persistent endometrial carcinoma: a study by the Gynecologic Oncology Group. Gynecol Oncol. 2008 Oct;111(1):22-6. link to original article contains verified protocol PubMed
Fluorouracil & Folinic acid
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Regimen #1
Study | Evidence |
Look et al. 1996 | Phase II |
Look et al. 1997 | Phase II |
Chemotherapy
- Folinic acid (Leucovorin) 200 mg/m2 IV bolus once per day on days 1 to 5, given first
- Fluorouracil (5-FU) 370 mg/m2 IV bolus over 5 minutes once per day on days 1 to 5, given second
28-day cycle for 2 cycles, then 35-day cycles given until progression of disease or unacceptable toxicity
Regimen #2
Study | Evidence |
Look et al. 1992 | Phase II |
Chemotherapy
- Folinic acid (Leucovorin) 20 mg/m2 IV once per day on days 1 to 5, given first
- Fluorouracil (5-FU) 425 mg/m2 IV once per day on days 1 to 5, given second
28-day cycle for 2 cycles, then 35-day cycles given until progression of disease or unacceptable toxicity
References
- Look KY, Blessing JA, Muss HB, Partridge EE, Malfetano JH. 5-fluorouracil and low-dose leucovorin in the treatment of recurrent squamous cell carcinoma of the cervix. A phase II trial of the Gynecologic Oncology Group. Am J Clin Oncol. 1992 Dec;15(6):497-9. PubMed
- Look KY, Blessing JA, Gallup DG, Lentz SS. A phase II trial of 5-fluorouracil and high-dose leucovorin in patients with recurrent squamous cell carcinoma of the cervix: a Gynecologic Oncology Group study. Am J Clin Oncol. 1996 Oct;19(5):439-41. PubMed
- Look KY, Blessing JA, Valea FA, McGehee R, Manetta A, Webster KD, Andersen WA. Phase II trial of 5-fluorouracil and high-dose leucovorin in recurrent adenocarcinoma of the cervix: a Gynecologic Oncology Group study. Gynecol Oncol. 1997 Dec;67(3):255-8. link to original article contains verified protocol PubMed
Gemcitabine monotherapy
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Regimen
Study | Evidence |
Schilder et al. 2000 (GOG 127-K) | Phase II |
Schilder et al. 2005 | Phase II |
Chemotherapy
- Gemcitabine (Gemzar) 800 mg/m2 IV over 30 minutes once per day on days 1, 8, 15
28-day cycles
References
- Schilder RJ, Blessing JA, Morgan M, Mangan CE, Rader JS. Evaluation of gemcitabine in patients with squamous cell carcinoma of the cervix: a Phase II study of the gynecologic oncology group. Gynecol Oncol. 2000 Feb;76(2):204-7. link to original article contains verified protocol PubMed
- Schilder RJ, Blessing J, Cohn DE. Evaluation of gemcitabine in previously treated patients with non-squamous cell carcinoma of the cervix: a phase II study of the Gynecologic Oncology Group. Gynecol Oncol. 2005 Jan;96(1):103-7. link to original article contains verified protocol PubMed
Ifosfamide monotherapy
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Regimen
Study | Evidence |
Coleman et al. 1986 | Phase II |
Sutton et al. 1993 | Phase II |
Sutton et al. 1993 | Phase II |
Chemotherapy
- Ifosfamide (Ifex) 1500 mg/m2 IV once per day on days 1 to 5
- Dosage for patients with previous pelvic radiation or other chemotherapy is 1200 mg/m2
- Dose could be increased by 300 mg/m2 or decreased by 20% depending on toxicity
Supportive medications
- Mesna (Mesnex) at 20% of ifosfamide dose (for example, 300 mg/m2 for 1500 mg/m2 dose of ifosfamide) IV given at 0, 4, and 8 hours after each dose of ifosfamide on days 1 to 5
21-day cycles
References
- Coleman RE, Harper PG, Gallagher C, Osborne R, Rankin EM, Silverstone AC, Slevin ML, Souhami RL, Tobias JS, Trask CW et al. A phase II study of ifosfamide in advanced and relapsed carcinoma of the cervix. Cancer Chemother Pharmacol. 1986;18(3):280-3. PubMed
- Sutton GP, Blessing JA, McGuire WP, Patton T, Look KY. Phase II trial of ifosfamide and mesna in patients with advanced or recurrent squamous carcinoma of the cervix who had never received chemotherapy: a Gynecologic Oncology Group study. Am J Obstet Gynecol. 1993 Mar;168(3 Pt 1):805-7. PubMed
- Sutton GP, Blessing JA, DiSaia PJ, McGuire WP. Phase II study of ifosfamide and mesna in nonsquamous carcinoma of the cervix: a Gynecologic Oncology Group study. Gynecol Oncol. 1993 Apr;49(1):48-50. link to original article contains verified protocol PubMed
Irinotecan monotherapy
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Regimen
Study | Evidence |
Verschraegen et al. 1997 | Phase II |
Chemotherapy
- Irinotecan (Camptosar) 125 mg/m2 IV over 90 minutes once per day on days 1, 8, 15, 22
Supportive medications
- Diphenhydramine (Benadryl) 25 to 50 mg PO/IV every 6 hours as needed for diarrhea during irinotecan infusion
- Atropine 1 mg IV every 6 hours as needed for diarrhea during irinotecan infusion
- Loperamide (Lomotil) 4 mg PO as needed for each episode of delayed diarrhea between irinotecan infusions
42-day cycles
References
- Verschraegen CF, Levy T, Kudelka AP, Llerena E, Ende K, Freedman RS, Edwards CL, Hord M, Steger M, Kaplan AL, Kieback D, Fishman A, Kavanagh JJ. Phase II study of irinotecan in prior chemotherapy-treated squamous cell carcinoma of the cervix. J Clin Oncol. 1997 Feb;15(2):625-31. link to original article contains verified protocol PubMed
Paclitaxel monotherapy
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Regimen #1, CI paclitaxel
Study | Evidence |
McGuire et al. 1996 | Phase II |
Curtin et al. 2001 | Phase II |
Chemotherapy
- Paclitaxel (Taxol) 170 mg/m2 IV continuous infusion over 24 hours on day 1
- Dosage for patients with previous pelvic radiation was 135 mg/m2
- Dose could be changed to 110 or 200 mg/m2 depending on toxicity
Supportive medications
- Dexamethasone (Decadron) 20 mg PO/IV 14 and 7 hours prior to paclitaxel
- Diphenhydramine (Benadryl) 50 mg IV 30 minutes prior to paclitaxel
- Ranitidine (Zantac) 50 mg IV 30 minutes prior to paclitaxel
21-day cycles
Regimen #2
Study | Evidence |
Kudelka et al. 1996 | Phase II |
Chemotherapy
- Paclitaxel (Taxol) 250 mg/m2 IV over 3 hours on day 1
- Dose could be changed to 275, 225, or 200 mg/m2 depending on toxicity
Supportive medications
- Dexamethasone (Decadron) 20 mg PO 14 and 7 hours prior to paclitaxel
- Cimetidine (Tagamet) 300 mg IV 60 minutes prior to paclitaxel
- Diphenhydramine (Benadryl) 50 mg IV 60 minutes prior to paclitaxel
- Filgrastim (Neupogen) 5 mcg/kg SC once per day starting on day 2, 24 hours after chemotherapy, given until day 19 or until ANC greater or equal to 10,000/uL
21-day cycles
References
- McGuire WP, Blessing JA, Moore D, Lentz SS, Photopulos G. Paclitaxel has moderate activity in squamous cervix cancer. A Gynecologic Oncology Group study. J Clin Oncol. 1996 Mar;14(3):792-5. link to original article contains verified protocol PubMed
- Kudelka AP, Winn R, Edwards CL, Downey G, Greenberg H, Dakhil SR, Freedman RS, Loyer E, Rusinkiewicz J, Gacrama P, Fueger R, Kavanagh JJ. Activity of paclitaxel in advanced or recurrent squamous cell cancer of the cervix. Clin Cancer Res. 1996 Aug;2(8):1285-8. link to original article contains verified protocol PubMed content property of HemOnc.org
- Update: Kudelka AP, Winn R, Edwards CL, Downey G, Greenberg H, Dakhil SR, Freedman RS, LoCoco S, Umbreit J, Delmore JE, Arbuck S, Loyer E, Gacrama P, Fueger R, Kavanagh JJ. An update of a phase II study of paclitaxel in advanced or recurrent squamous cell cancer of the cervix. Anticancer Drugs. 1997 Aug;8(7):657-61. PubMed
- Curtin JP, Blessing JA, Webster KD, Rose PG, Mayer AR, Fowler WC Jr, Malfetano JH, Alvarez RD. Paclitaxel, an active agent in nonsquamous carcinomas of the uterine cervix: a Gynecologic Oncology Group Study. J Clin Oncol. 2001 Mar 1;19(5):1275-8. link to original article contains verified protocol PubMed
Pemetrexed monotherapy
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Regimen
Study | Evidence |
Miller et al. 2008 | Phase II |
Chemotherapy
- Pemetrexed (Alimta) 900 mg/m2 IV over 10 minutes once on day 1
Supportive medications
- Folic acid 350 to 600 mcg PO once per day, starting 7 days before pemetrexed, to continue throughout therapy
- Cyanocobalamin (Vitamin B12) 1000 mcg IM once 7 days before pemetrexed (then 1000 mcg to be given every 9 weeks thereafter)
- Dexamethasone (Decadron) 4 mg PO BID the day before, the day of, and day after pemetrexed
- No NSAIDs (nonsteroidal anti-inflammatory drugs) for 2 days before or after pemetrexed
21-day cycles
References
- Miller DS, Blessing JA, Bodurka DC, Bonebrake AJ, Schorge JO; Gynecologic Oncology Group. Evaluation of pemetrexed (Alimta, LY231514) as second line chemotherapy in persistent or recurrent carcinoma of the cervix: a phase II study of the Gynecologic Oncology Group. Gynecol Oncol. 2008 Jul;110(1):65-70. Epub 2008 May 5. link to original article contains verified protocol PubMed
Topotecan monotherapy
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Regimen #1, 4-week cycle
Study | Evidence |
Muderspach et al. 2001 | Phase II |
Chemotherapy
- Topotecan (Hycamtin) 1.5 mg/m2 IV over 30 minutes once per day on days 1 to 5
28-day cycles
Regimen #2, 3-week cycle
Study | Evidence |
Bookman et al. 2000 (GOG 127-F) | Phase II |
Chemotherapy
- Topotecan (Hycamtin) 1.5 mg/m2 IV over 30 minutes once per day on days 1 to 5
21-day cycles
References
- Bookman MA, Blessing JA, Hanjani P, Herzog TJ, Andersen WA. Topotecan in squamous cell carcinoma of the cervix: A Phase II study of the Gynecologic Oncology Group. Gynecol Oncol. 2000 Jun;77(3):446-9. link to original article contains verified protocol PubMed
- Muderspach LI, Blessing JA, Levenback C, Moore JL Jr. A Phase II study of topotecan in patients with squamous cell carcinoma of the cervix: a gynecologic oncology group study. Gynecol Oncol. 2001 May;81(2):213-5. link to original article contains verified protocol PubMed
Topotecan & Paclitaxel
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TP: Topotecan, Paclitaxel
Regimen
Study | Evidence | Comparator | Efficacy |
Tewari et al. 2014 (GOG 240) | Phase III | Cisplatin & Paclitaxel | Seems not superior |
Cisplatin, Paclitaxel, Bevacizumab | Not reported | ||
Topotecan, Paclitaxel, Bevacizumab | Might have inferior OS |
In GOG 240, topotecan & paclitaxel +/- bevacizumab regimens were "associated with a significantly higher risk of progression" as compared to cisplatin & paclitaxel +/- bevacizumab regimens.
Chemotherapy
- Topotecan (Hycamtin) 0.75 mg/m2 IV once per day on days 1 to 3
- Paclitaxel (Taxol) 175 mg/m2 IV once on day 1
21-day cycles; given until progression of disease, unacceptable toxicity, or if the patient had a complete response
References
- Tewari KS, Sill MW, Long HJ 3rd, Penson RT, Huang H, Ramondetta LM, Landrum LM, Oaknin A, Reid TJ, Leitao MM, Michael HE, Monk BJ. Improved survival with bevacizumab in advanced cervical cancer. N Engl J Med. 2014 Feb 20;370(8):734-43. link to original article link to supplementary appendix contains verified protocol link to PMC article PubMed
Topotecan, Paclitaxel, Bevacizumab
back to top |
TP+Bev: Topotecan, Paclitaxel, Bevacizumab
Regimen
Study | Evidence | Comparator | Efficacy |
Tewari et al. 2014 (GOG 240) | Phase III | Cisplatin & Paclitaxel | Not reported |
Cisplatin, Paclitaxel, Bevacizumab | Not reported | ||
Topotecan & Paclitaxel | Might have superior OS |
In GOG 240, topotecan & paclitaxel +/- bevacizumab regimens were "associated with a significantly higher risk of progression" as compared to cisplatin & paclitaxel +/- bevacizumab regimens.
Chemotherapy
- Topotecan (Hycamtin) 0.75 mg/m2 IV once per day on days 1 to 3
- Paclitaxel (Taxol) 175 mg/m2 IV once on day 1
- Bevacizumab (Avastin) 15 mg/kg IV once on day 1
21-day cycles; given until progression of disease, unacceptable toxicity, or if the patient had a complete response
References
- Tewari KS, Sill MW, Long HJ 3rd, Penson RT, Huang H, Ramondetta LM, Landrum LM, Oaknin A, Reid TJ, Leitao MM, Michael HE, Monk BJ. Improved survival with bevacizumab in advanced cervical cancer. N Engl J Med. 2014 Feb 20;370(8):734-43. link to original article link to supplementary appendix contains verified protocol link to PMC article PubMed
Vinorelbine monotherapy
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Regimen #1, 2 weeks on, 1 week off dosing
Study | Evidence | ORR |
Muggia et al. 2004 | Phase II | 14% (95% CI 5-27%) |
Muggia et al. 2005 | Phase II | 7% |
Chemotherapy
- Vinorelbine (Navelbine) 30 mg/m2 IV once per day on days 1 & 8
21-day cycles
Regimen #2, weekly dosing
Study | Evidence | ORR |
Morris et al. 1998 | Phase II | 18% |
Chemotherapy
- Vinorelbine (Navelbine) 30 mg/m2 IV once on day 1
7-day cycles
References
- Morris M, Brader KR, Levenback C, Burke TW, Atkinson EN, Scott WR, Gershenson DM. Phase II study of vinorelbine in advanced and recurrent squamous cell carcinoma of the cervix. J Clin Oncol. 1998 Mar;16(3):1094-8. link to original article contains verified protocol PubMed
- Muggia FM, Blessing JA, Method M, Miller DS, Johnson GA, Lee RB, Menzin A; Gynecologic Oncology Group study. Evaluation of vinorelbine in persistent or recurrent squamous cell carcinoma of the cervix: a Gynecologic Oncology Group study. Gynecol Oncol. 2004 Feb;92(2):639-43. link to original article contains verified protocol PubMed
- Muggia FM, Blessing JA, Waggoner S, Berek JS, Monk BJ, Sorosky J, Pearl ML. Evaluation of vinorelbine in persistent or recurrent nonsquamous carcinoma of the cervix: a Gynecologic Oncology Group Study. Gynecol Oncol. 2005 Jan;96(1):108-11. link to original article contains verified protocol PubMed