Difference between revisions of "Cervical cancer"

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===Regimen #1, 2 weeks on, 1 week off dosing {{#subobject:ba6a7e|Variant=1}}===
 
===Regimen #1, 2 weeks on, 1 week off dosing {{#subobject:ba6a7e|Variant=1}}===

Revision as of 04:03, 24 October 2016

Use of this site is subject to you reading and agreeing with the terms set forth in the disclaimer.

Is there a regimen missing from this list? Would you like to share a different dosage/schedule or an additional reference for a regimen? Have you noticed an error? Do you have an idea that will help the site grow to better meet your needs and the needs of many others? You are invited to contribute to the site.

49 regimens on this page
65 variants on this page


Chemoradiation

Cisplatin & RT

back to top

RT: Radiation Therapy

Regimen #1

Study Evidence Comparator
Dueñas-González et al. 2011 Phase III Cisplatin, Gemcitabine, RT

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
Lanciano et al. 2005 (GOG 165) Phase III Fluorouracil & RT

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
Rose et al. 1999 (GOG 120) Phase III Cisplatin, Fluorouracil, Hydroxyurea, RT
Hydroxyurea & RT

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

  1. 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
    1. 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
  2. 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
  3. 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

Cisplatin & RT -> Hysterectomy

back to top

RT: Radiation Therapy

Regimen

Study Evidence Comparator
Keys et al. 1999 (GOG 123) Phase III RT -> Hysterectomy

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

  1. 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
Whitney et al. 1999 (GOG 85/SWOG 8695) Phase III Hydroxyurea & RT
Peters et al. 2000 (GOG 109/SWOG-8797) Phase III Radiation therapy

Chemotherapy

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

  1. 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
  2. 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
Rose et al. 1999 (GOG 120) Phase III Cisplatin & RT
Hydroxyurea & RT

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

  1. 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
    1. 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
Dueñas-González et al. 2011 Phase III Cisplatin & RT

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

21-day cycle for 2 cycles

References

  1. 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
Lanciano et al. 2005 (GOG 165) Phase III Cisplatin & RT

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

  1. 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
Hreshchyshyn et al. 1979 (GOG 04) Phase III Radiation therapy
Rose et al. 1999 (GOG 120) Phase III Cisplatin & RT
Cisplatin, Fluorouracil, Hydroxyurea, RT
Whitney et al. 1999 (GOG 85/SWOG 8695) Phase III Cisplatin, Fluorouracil, RT

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

  1. 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 article PubMed
  2. 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
    1. 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
  3. 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
Peters et al. 2000 (GOG 109/SWOG-8797) Phase III Cisplatin, Fluorouracil, RT

Demonstrably inferior; here for reference purposes only.

References

  1. 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

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RT: Radiation Therapy

Regimen

Study Evidence Comparator
Hreshchyshyn et al. 1979 (GOG 04) Phase III Hydroxyurea & RT
Keys et al. 1999 (GOG 123) Phase III Cisplatin & RT -> Hysterectomy

Demonstrably inferior; here for reference purposes only.

References

  1. 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 article PubMed
  2. 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

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Regimen

Study Evidence
Park et al. 2004 Phase II

Chemotherapy

Supportive medications

10-day cycle for 3 cycles

Clinical response assessed after 3 cycles with pelvic examination and MRI.

References

  1. 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 (Avastin)

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Regimen

Study Evidence
Monk et al. 2009 (GOG 227-C) Phase II

Chemotherapy

21-day cycles

References

  1. 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 PubMed

Carboplatin (Paraplatin)

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Regimen

Study Evidence
Weiss et al. 1990 Phase II

Chemotherapy

28-day cycles

References

  1. 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

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Regimen

Study Evidence
Nagao et al. 2005 Phase II

Chemotherapy

Supportive medications

21-day cycles

References

  1. 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
  2. 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

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Regimen

Study Evidence
Pectasides et al. 2009 Phase II

Chemotherapy

21-day cycle for 6 to 9 cycles

References

  1. 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 (Platinol)

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Regimen

Study Evidence Comparator
Moore et al. 2004 Phase III Cisplatin & Paclitaxel
Long et al. 2005 Phase III Cisplatin & Topotecan

Chemotherapy

21-day cycles; if not responding, given for maximum of 6 cycles

References

  1. 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
  2. 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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Regimen #1, 3-week cycles

Study Evidence Comparator
Monk et al. 2009 Phase III Cisplatin & Paclitaxel
Cisplatin & Topotecan
Cisplatin & Vinorelbine

Chemotherapy

21-day cycles

Regimen #2, 4-week cycles

Study Evidence
Brewer et al. 2006 Phase II

Chemotherapy

28-day cycles

References

  1. 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
  2. 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 PubMed

Cisplatin & Mitomycin

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Regimen

Study Evidence
Wagenaar et al. 2001 Phase II

Note: The NCCN, Cervical Cancer version 1.2012, lists mitomycin monotherapy as a potential second-line therapy option, and cites the reference below, which describes a two-drug regimen. No primary reference for the monotherapy regimen could be found.

Chemotherapy

Supportive medications

28-day cycle for 9 cycles

References

  1. 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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Regimen #1

Study Evidence Comparator
Tewari et al. 2014 (GOG 240) Phase III Cisplatin, Paclitaxel, Bevacizumab
Topotecan & Paclitaxel
Topotecan, Paclitaxel, Bevacizumab

Chemotherapy

21-day cycles, given until progression of disease, unacceptable toxicity, or if the patient had a complete response

Regimen #2, CI paclitaxel

Study Evidence Comparator
Moore et al. 2004 Phase III Cisplatin
Monk et al. 2009 Phase III Cisplatin & Gemcitabine
Cisplatin & Topotecan
Cisplatin & Vinorelbine

Chemotherapy

Supportive medications

21-day cycles; if not responding, given for maximum of 6 cycles.

References

  1. 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
  2. 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 PubMed
  3. 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 PubMed

Cisplatin, Paclitaxel, Bevacizumab

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Regimen

Study Evidence Comparator
Tewari et al. 2014 (GOG 240) Phase III Cisplatin & Paclitaxel
Topotecan & Paclitaxel
Topotecan, Paclitaxel, Bevacizumab

Chemotherapy

21-day cycles; given until progression of disease, unacceptable toxicity, or if the patient had a complete response

References

  1. 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 PubMed

Cisplatin & Topotecan

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Regimen

Study Evidence Comparator
Long et al. 2005 Phase III Cisplatin
Monk et al. 2009 Phase III Cisplatin & Gemcitabine
Cisplatin & Paclitaxel
Cisplatin & Vinorelbine

Chemotherapy

21-day cycles; if not responding, given for maximum of 6 cycles

References

  1. 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
  2. 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 PubMed

Cisplatin & Vinorelbine

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Regimen

Study Evidence Comparator
Monk et al. 2009 Phase III Cisplatin & Gemcitabine
Cisplatin & Paclitaxel
Cisplatin & Topotecan

Chemotherapy

21-day cycles; if not responding, given for maximum of 6 cycles

References

  1. 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 PubMed

Docetaxel (Taxotere)

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Regimen #1, 4-week cycles

Study Evidence
Garcia et al. 2008 Phase II

Chemotherapy

Supportive medications

28-day cycles

Regimen #2, 3-week cycles

Study Evidence
Garcia et al. 2007 Phase II

Chemotherapy

21-day cycles

References

  1. 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
  2. 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

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

28-day cycle for 2 cycles, then 35-day cycles given until progression of disease or unacceptable toxicity

References

  1. 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
  2. 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
  3. 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 (Gemzar)

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Regimen

Study Evidence
Schilder et al. 2000 (GOG 127-K) Phase II
Schilder et al. 2005 Phase II

Chemotherapy

28-day cycles

References

  1. 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
  2. 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 (Ifex)

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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

  1. 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
  2. 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
  3. 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 (Camptosar)

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Regimen

Study Evidence
Verschraegen et al. 1997 Phase II

Chemotherapy

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

  1. 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 (Taxol)

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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

21-day cycles

Regimen #2

Study Evidence
Kudelka et al. 1996 Phase II

Chemotherapy

Supportive medications

21-day cycles

References

  1. 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
  2. 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
    1. 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
  3. 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 (Alimta)

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Regimen

Study Evidence
Miller et al. 2008 Phase II

Chemotherapy

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

  1. 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 (Hycamtin)

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Regimen #1, 4-week cycle

Study Evidence
Muderspach et al. 2001 Phase II

Chemotherapy

28-day cycles

Regimen #2, 3-week cycle

Study Evidence
Bookman et al. 2000 (GOG 127-F) Phase II

Chemotherapy

21-day cycles

References

  1. 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
  2. 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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Regimen

Study Evidence Comparator
Tewari et al. 2014 (GOG 240) Phase III Cisplatin & Paclitaxel
Cisplatin, Paclitaxel, Bevacizumab
Topotecan, Paclitaxel, Bevacizumab

In Tewari et al. 2014 (GOG 240), topotecan & paclitaxel +/- bevacizumab regimens were "associated with a significantly higher risk of progression" as compared to cisplatin & paclitaxel +/- bevacizumab regimens.

Chemotherapy

21-day cycles; given until progression of disease, unacceptable toxicity, or if the patient had a complete response

References

  1. 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 PubMed

Topotecan, Paclitaxel, Bevacizumab

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Regimen

Study Evidence Comparator
Tewari et al. 2014 (GOG 240) Phase III Cisplatin & Paclitaxel
Cisplatin, Paclitaxel, Bevacizumab
Topotecan & Paclitaxel

In Tewari et al. 2014 (GOG 240), topotecan & paclitaxel +/- bevacizumab regimens were "associated with a significantly higher risk of progression" as compared to cisplatin & paclitaxel +/- bevacizumab regimens.

Chemotherapy

21-day cycles; given until progression of disease, unacceptable toxicity, or if the patient had a complete response

References

  1. 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 PubMed

Vinorelbine (Navelbine)

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Regimen #1, 2 weeks on, 1 week off dosing

Study Evidence
Muggia et al. 2004 Phase II
Muggia et al. 2005 Phase II

Chemotherapy

21-day cycles

Regimen #2, weekly dosing

Study Evidence
Morris et al. 1998 Phase II

Chemotherapy

7-day cycles

References

  1. 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
  2. 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
  3. 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
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