Difference between revisions of "Cervical cancer - historical"
Jump to navigation
Jump to search
m (→References) |
|||
Line 174: | Line 174: | ||
## '''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 Oct 7;390(10103):1654-1663. Epub 2017 Jul 27. [https://doi.org/10.1016/s0140-6736(17)31607-0 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc5714293/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/28756902/ 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 Oct 7;390(10103):1654-1663. Epub 2017 Jul 27. [https://doi.org/10.1016/s0140-6736(17)31607-0 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc5714293/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/28756902/ PubMed] | ||
## '''Update:''' Tewari KS, Sill MW, Birrer MJ, Penson RT, Huang H, Moore DH, Ramondetta LM, Landrum LM, Oaknin A, Reid TJ, Leitao MM, Michael HE, Monk BJ. Final survival analysis of topotecan and paclitaxel for first-line treatment of advanced cervical cancer: An NRG oncology randomized study. Gynecol Oncol. 2023 Apr;171:141-150. Epub 2023 Mar 8. [https://doi.org/10.1016/j.ygyno.2023.01.010 link to original article] [https://pubmed.ncbi.nlm.nih.gov/36898292/ PubMed] | ## '''Update:''' Tewari KS, Sill MW, Birrer MJ, Penson RT, Huang H, Moore DH, Ramondetta LM, Landrum LM, Oaknin A, Reid TJ, Leitao MM, Michael HE, Monk BJ. Final survival analysis of topotecan and paclitaxel for first-line treatment of advanced cervical cancer: An NRG oncology randomized study. Gynecol Oncol. 2023 Apr;171:141-150. Epub 2023 Mar 8. [https://doi.org/10.1016/j.ygyno.2023.01.010 link to original article] [https://pubmed.ncbi.nlm.nih.gov/36898292/ PubMed] | ||
+ | #'''AGO-Zervix-1:''' Gass P, Thiel FC, Häberle L, Ackermann S, Theuser AK, Hummel N, Boehm S, Kimmig R, Reinthaller A, Becker S, Hilpert F, Janni W, Vergote I, Harter P, Emons J, Hein A, Beckmann MW, Fasching PA, Pöschke P; AGO Uterus Commission. Primary results of the AGO-Zervix-1 Study: A prospective, randomized phase III study to compare the effects of paclitaxel and topotecan with those of cisplatin and topotecan in the treatment of patients with recurrent and persistent cervical cancer. Gynecol Oncol. 2024 Apr;183:25-32. Epub 2024 Mar 14. [https://doi.org/10.1016/j.ygyno.2024.03.002 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/38490057/ PubMed] [https://clinicaltrials.gov/study/NCT01405235 NCT01405235] | ||
[[Category:Cervical cancer regimens]] | [[Category:Cervical cancer regimens]] |
Latest revision as of 11:33, 2 July 2024
The purpose of this page is to provide references to regimens that are obsolete, outdated, or of historical interest only. Is there a regimen missing from this list? See the main cervical cancer page for current regimens.
3 regimens on this page
3 variants on this page
|
Definitive therapy for locally advanced disease
Fluorouracil, Mitomycin, RT
Fluorouracil, Mitomycin, RT: Fluorouracil, Mitomycin, Radiation Therapy
Regimen
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Lorvidhava et al. 2003 | 1988-1994 | Phase 3 (E-esc) | RT | Superior DFS |
Chemotherapy
- Fluorouracil (5-FU) 300 mg PO once per day on days 1 to 14, 29 to 42
- Mitomycin (Mutamycin) 10 mg/m2 IV once per day on days 1 & 29
Radiotherapy
- Concurrent radiation therapy
One course
References
- Lorvidhaya V, Chitapanarux I, Sangruchi S, Lertsanguansinchai P, Kongthanarat Y, Tangkaratt S, Visetsiri E. Concurrent mitomycin C, 5-fluorouracil, and radiotherapy in the treatment of locally advanced carcinoma of the cervix: a randomized trial. Int J Radiat Oncol Biol Phys. 2003 Apr 1;55(5):1226-32. link to original article contains dosing details in manuscript PubMed
Radiation therapy
Regimen
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Hreshchyshyn et al. 1979 (GOG 04) | 1970-1976 | Phase 3 (C) | Hydroxyurea & RT | Seems to have inferior OS |
Benedetti-Panici et al. 2002 | 1990-1996 | Phase 3 (C) | NACT, then surgery | Inferior OS |
Morris et al. 1999 (RTOG 9001) | 1990-1997 | Phase 3 (C) | Cisplatin & RT | Inferior OS |
Peters et al. 2000 (GOG 109/SWOG-8797) | 1991-1996 | Phase 3 (C) | Cisplatin, Fluorouracil, RT | Inferior OS |
Pearcey et al. 2002 | 1991-1996 | Phase 3 (C) | Cisplatin & RT | Did not meet primary endpoint of OS36 |
Keys et al. 1999 (GOG 123) | 1992-1997 | Phase 3 (C) | Cisplatin & RT | Inferior OS |
Shrivastava et al. 2018 (CRACx) | 2003-2011 | Phase 3 (C) | Cisplatin & RT | Seems to have inferior OS |
Sugiyama et al. 2014 (JGOG-DT101) | 2004-2006 | Phase 3 (C) | Z-100 & RT | Did not meet primary endpoint of OS |
Srivastava et al. 2013 | 2006-2008 | Phase 3 (C) | Cisplatin & RT | Did not meet primary endpoint of LRFS |
Huang et al. 2021 (STARS) | 2008-2018 | Phase 3 (C) | 1. Cisplatin & RT | Did not meet primary endpoint of DFS |
2. Cisplatin & Paclitaxel x2, then RT, then Cisplatin & Paclitaxel x2 | Seems to have inferior OS |
Note: Demonstrably inferior; here for reference purposes only.
Radiotherapy
Subsequent treatment
- GOG 04 & GOG 123: adjuvant hysterectomy
References
- GOG 04: 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
- DiSaia PJ, Bundy BN, Curry SL, Schlaerth J, Thigpen JT. Phase III study on the treatment of women with cervical cancer, stage IIB, IIIB, and IVA (confined to the pelvis and/or periaortic nodes), with radiotherapy alone versus radiotherapy plus immunotherapy with intravenous Corynebacterium parvum: a Gynecologic Oncology Group Study. Gynecol Oncol. 1987 Mar;26(3):386-97. link to original article PubMed
- RTOG 9001: Morris M, Eifel PJ, Lu J, Grigsby PW, Levenback C, Stevens RE, Rotman M, Gershenson DM, Mutch DG. Pelvic radiation with concurrent chemotherapy compared with pelvic and para-aortic radiation for high-risk cervical cancer. N Engl J Med. 1999 Apr 15;340(15):1137-43. link to original article contains dosing details in manuscript PubMed
- GOG 123: 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 dosing details in manuscript PubMed
- GOG 109/SWOG-8797: 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 dosing details in manuscript PubMed
- Benedetti-Panici P, Greggi S, Colombo A, Amoroso M, Smaniotto D, Giannarelli D, Amunni G, Raspagliesi F, Zola P, Mangioni C, Landoni F. Neoadjuvant chemotherapy and radical surgery versus exclusive radiotherapy in locally advanced squamous cell cervical cancer: results from the Italian multicenter randomized study. J Clin Oncol. 2002 Jan 1;20(1):179-88. link to original article PubMed
- Pearcey R, Brundage M, Drouin P, Jeffrey J, Johnston D, Lukka H, MacLean G, Souhami L, Stuart G, Tu D. Phase III trial comparing radical radiotherapy with and without cisplatin chemotherapy in patients with advanced squamous cell cancer of the cervix. J Clin Oncol. 2002 Feb 15;20(4):966-72. link to original article contains dosing details in manuscript PubMed
- Srivastava K, Paul S, Chufal KS, Shamsundar SD, Lal P, Pant MC, Bhatt M, Singh S, Gupta R. Concurrent chemoradiation versus radiotherapy alone in cervical carcinoma: a randomized phase III trial. Asia Pac J Clin Oncol. 2013 Dec;9(4):349-56. Epub 2013 May 27. link to original article PubMed
- JGOG-DT101: Sugiyama T, Fujiwara K, Ohashi Y, Yokota H, Hatae M, Ohno T, Nagai Y, Mitsuhashi N, Ochiai K, Noda K. Phase III placebo-controlled double-blind randomized trial of radiotherapy for stage IIB-IVA cervical cancer with or without immunomodulator Z-100: a JGOG study. Ann Oncol. 2014 May;25(5):1011-7. Epub 2014 Feb 25. link to original article PubMed UMIN C000000221
- CRACx: Shrivastava S, Mahantshetty U, Engineer R, Chopra S, Hawaldar R, Hande V, Kerkar RA, Maheshwari A, Shylasree TS, Ghosh J, Bajpai J, Gurram L, Gulia S, Gupta S; Gynecologic Disease Management Group. Cisplatin chemoradiotherapy vs radiotherapy in FIGO stage IIIB squamous cell carcinoma of the uterine cervix: a randomized clinical trial. JAMA Oncol. 2018 Apr 1;4(4):506-513. link to original article contains dosing details in supplement link to PMC article PubMed NCT00193791
- STARS: Huang H, Feng YL, Wan T, Zhang YN, Cao XP, Huang YW, Xiong Y, Huang X, Zheng M, Li YF, Li JD, Chen GD, Li H, Chen YL, Ma LG, Yang HY, Li L, Yao SZ, Ye WJ, Tu H, Huang QD, Liang LZ, Liu FY, Liu Q, Liu JH. Effectiveness of Sequential Chemoradiation vs Concurrent Chemoradiation or Radiation Alone in Adjuvant Treatment After Hysterectomy for Cervical Cancer: The STARS Phase 3 Randomized Clinical Trial. JAMA Oncol. 2021 Mar 1;7(3):361-369. link to original article link to PMC article PubMed NCT00806117
Persistent, recurrent, or metastatic disease, first-line therapy
Paclitaxel & Topotecan
TP: Topotecan, Paclitaxel
Regimen
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Tewari et al. 2014 (GOG 240) | 2009-2012 | Phase 3 (C) | 1. Cisplatin & Paclitaxel | Did not meet primary endpoint of OS |
2. Cisplatin, Paclitaxel, Bevacizumab | Not reported | |||
3. Paclitaxel, Topotecan, Bevacizumab | Did not meet primary endpoint of OS1 |
1Reported efficacy is based on the 2017 update.
Note: per the initial report, topotecan & paclitaxel +/- bevacizumab regimens were "associated with a significantly higher risk of progression" as compared to cisplatin & paclitaxel +/- bevacizumab regimens.
Chemotherapy
- Paclitaxel (Taxol) 175 mg/m2 IV once on day 1
- Topotecan (Hycamtin) 0.75 mg/m2 IV once per day on days 1 to 3
21-day cycles
References
- GOG 240: 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 dosing details in manuscript link to PMC article PubMed NCT00803062
- 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 Oct 7;390(10103):1654-1663. Epub 2017 Jul 27. link to original article link to PMC article PubMed
- Update: Tewari KS, Sill MW, Birrer MJ, Penson RT, Huang H, Moore DH, Ramondetta LM, Landrum LM, Oaknin A, Reid TJ, Leitao MM, Michael HE, Monk BJ. Final survival analysis of topotecan and paclitaxel for first-line treatment of advanced cervical cancer: An NRG oncology randomized study. Gynecol Oncol. 2023 Apr;171:141-150. Epub 2023 Mar 8. link to original article PubMed
- AGO-Zervix-1: Gass P, Thiel FC, Häberle L, Ackermann S, Theuser AK, Hummel N, Boehm S, Kimmig R, Reinthaller A, Becker S, Hilpert F, Janni W, Vergote I, Harter P, Emons J, Hein A, Beckmann MW, Fasching PA, Pöschke P; AGO Uterus Commission. Primary results of the AGO-Zervix-1 Study: A prospective, randomized phase III study to compare the effects of paclitaxel and topotecan with those of cisplatin and topotecan in the treatment of patients with recurrent and persistent cervical cancer. Gynecol Oncol. 2024 Apr;183:25-32. Epub 2024 Mar 14. link to original article contains dosing details in manuscript PubMed NCT01405235