Cervical cancer - historical

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The purpose of this page is to provide references to regimens that are obsolete, outdated, or of historical interest only.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.
Last updated on 2024-07-23:3 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 	Longer 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 dosing details in manuscript have been reviewed by our editors EuroPMC
==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 shorter OS
Benedetti-Panici et al. 2002 	1990-1996 	Phase 3 (C)	NACT, then surgery 	Shorter OS
Morris et al. 1999 (RTOG 9001) 	1990-1997 	Phase 3 (C)	Cisplatin & RT 	Shorter OS
Peters et al. 2000 (GOG 109/SWOG-8797)	1991-1996 	Phase 3 (C)	Cisplatin, Fluorouracil, RT 	Shorter OSOS48: 71% vs 81%(HR 1.96)
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 	Shorter OS
Shrivastava et al. 2018 (CRACx) 	2003-2011 	Phase 3 (C)	Cisplatin & RT 	Seems to have shorter OSOS60: 46% vs 54%(HR 1.22, 95% CI 1.02-1.47)
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
Huang et al. 2021 (STARS) 	2008-2018 	Phase 3 (C)	2. Cisplatin & Paclitaxel x2, then RT, then Cisplatin & Paclitaxel x2	Seems to have shorter OS
Note: Demonstrably inferior; here for reference purposes only.
====Radiotherapy====
*External beam radiotherapy of varying regimens
One course
====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 EuroPMC
# 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 EuroPMC
# 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 dosing details in manuscript have been reviewed by our editors EuroPMC
# 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 dosing details in manuscript have been reviewed by our editors EuroPMC
# 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 dosing details in manuscript have been reviewed by our editors EuroPMC
# 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 EuroPMC
# 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 dosing details in manuscript have been reviewed by our editors EuroPMC
# 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 EuroPMC
# 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 EuroPMC 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 dosing details in supplement have been reviewed by our editors link to PMC article EuroPMC 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 EuroPMC 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
Tewari et al. 2014 (GOG 240)	2009-2012 	Phase 3 (C)	2. TP & Bevacizumab 	Not reported
Tewari et al. 2014 (GOG 240)	2009-2012 	Phase 3 (C)	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 dosing details in manuscript have been reviewed by our editors link to PMC article EuroPMC NCT00803062
##PRO analysis: Penson RT, Huang HQ, Wenzel LB, Monk BJ, Stockman S, Long HJ 3rd, Ramondetta LM, Landrum LM, Oaknin A, Reid TJ, Leitao MM, Method M, Michael H, Tewari KS. Bevacizumab for advanced cervical cancer: patient-reported outcomes of a randomised, phase 3 trial (NRG Oncology-Gynecologic Oncology Group protocol 240). Lancet Oncol. 2015 Mar;16(3):301-11. Epub 2015 Jan 29. Erratum in: Lancet Oncol. 2016 Jan;17(1):e6. link to original article link to PMC article EuroPMC
## 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 EuroPMC
## 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 link to PMC article EuroPMC
#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 dosing details in manuscript have been reviewed by our editors EuroPMC NCT01405235
Category:Cervical cancer regimens
Category:Historical regimens
Category:Disease-specific pages
Category:Gynecologic cancers