Cervical cancer - null regimens
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The purpose of this page is to provide references to "null therapy" such as placebo and observation. These references provide further insight into the historical development of the treatment landscape. See the main cervical cancer page for regimens that include active anticancer treatment.
Induction therapy
No induction therapy
Regimen
| Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
|---|---|---|---|---|
| Herod et al. 2000 | 1986-1995 | Phase 3 (C) | BIP | Did not meet co-primary endpoints of ORR/OS |
| McCormack et al. 2024 (INTERLACE) | 2012-11-08 to 2022-11-17 | Phase 3 (C) | CP | Inferior PFS/OS |
No systemic therapy prior to definitive therapy.
Subsequent treatment
- Herod et al. 2000: Definitive RT
- INTERLACE: Cisplatin & RT consolidation
References
- Herod J, Burton A, Buxton J, Tobias J, Luesley D, Jordan S, Dunn J, Poole CJ. A randomised, prospective, phase III clinical trial of primary bleomycin, ifosfamide and cisplatin (BIP) chemotherapy followed by radiotherapy versus radiotherapy alone in inoperable cancer of the cervix. Ann Oncol. 2000 Sep;11(9):1175-81. link to original article PubMed
- INTERLACE: McCormack M, Eminowicz G, Gallardo D, Diez P, Farrelly L, Kent C, Hudson E, Panades M, Mathew T, Anand A, Persic M, Forrest J, Bhana R, Reed N, Drake A, Adusumalli M, Mukhopadhyay A, King M, Whitmarsh K, McGrane J, Colombo N, Mak C, Mandal R, Chowdhury RR, Alamilla-Garcia G, Chávez-Blanco A, Stobart H, Feeney A, Vaja S, Hacker AM, Hackshaw A, Ledermann JA; INTERLACE investigators. Induction chemotherapy followed by standard chemoradiotherapy versus standard chemoradiotherapy alone in patients with locally advanced cervical cancer (GCIG INTERLACE): an international, multicentre, randomised phase 3 trial. Lancet. 2024 Oct 19;404(10462):1525-1535. Epub 2024 Oct 14. link to original article PubMed NCT01566240
Neoadjuvant therapy
No neoadjuvant therapy
Regimen
| Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
|---|---|---|---|---|
| Eddy et al. 2007 (GOG 141) | 1996-2001 | Phase 3 (C) | Cisplatin & Vincristine | Did not meet co-primary endpoints of PFS/OS |
| Katsumata et al. 2013 (JCOG 0102) | 2001-2005 | Phase 3 (C) | BOMP | Did not meet primary endpoint of OS |
No systemic therapy prior to surgery.
Subsequent treatment
References
- GOG 141: Eddy GL, Bundy BN, Creasman WT, Spirtos NM, Mannel RS, Hannigan E, O'Connor D. Treatment of ("bulky") stage IB cervical cancer with or without neoadjuvant vincristine and cisplatin prior to radical hysterectomy and pelvic/para-aortic lymphadenectomy: a phase III trial of the Gynecologic Oncology Group. Gynecol Oncol. 2007 Aug;106(2):362-9. Epub 2007 May 9. link to original article PubMed
- JCOG 0102: Katsumata N, Yoshikawa H, Kobayashi H, Saito T, Kuzuya K, Nakanishi T, Yasugi T, Yaegashi N, Yokota H, Kodama S, Mizunoe T, Hiura M, Kasamatsu T, Shibata T, Kamura T; JCOG. Phase III randomised controlled trial of neoadjuvant chemotherapy plus radical surgery vs radical surgery alone for stages IB2, IIA2, and IIB cervical cancer: a Japan Clinical Oncology Group trial (JCOG 0102). Br J Cancer. 2013 May 28;108(10):1957-63. Epub 2013 May 2. link to original article link to PMC article PubMed NCT00190528
Adjuvant therapy
Observation
Regimen
| Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
|---|---|---|---|---|
| Mileshkin et al. 2023 (OUTBACK) | 2011-04-15 to 2017-06-26 | Phase 3 (C) | Carboplatin & Paclitaxel | Did not meet primary endpoint of OS60 OS60: 71% vs 72% |
| Tangjitgamol et al. 2019 (ACTLACC) | 2015-2017 | Phase 3 (C) | Carboplatin & Paclitaxel | Did not meet primary endpoint of PFS |
No further treatment after definitive therapy.
Preceding treatment
- Definitive cisplatin-based chemo-radiation
References
- ACTLACC: Tangjitgamol S, Tharavichitkul E, Tovanabutra C, Rongsriyam K, Asakij T, Paengchit K, Sukhaboon J, Penpattanagul S, Kridakara A, Hanprasertpong J, Chomprasert K, Wanglikitkoon S, Atjimakul T, Pariyawateekul P, Katanyoo K, Tanprasert P, Janweerachai W, Sangthawan D, Khunnarong J, Chottetanaprasith T, Supawattanabodee B, Lertsanguansinchai P, Srisomboon J, Isaranuwatchai W, Lorvidhaya V. A randomized controlled trial comparing concurrent chemoradiation versus concurrent chemoradiation followed by adjuvant chemotherapy in locally advanced cervical cancer patients: ACTLACC trial. J Gynecol Oncol. 2019 Jul;30(4):e82. Epub 2019 Apr 10. link to original article link to PMC article PubMed NCT02036164
- OUTBACK: Mileshkin LR, Moore KN, Barnes EH, Gebski V, Narayan K, King MT, Bradshaw N, Lee YC, Diamante K, Fyles AW, Small W Jr, Gaffney DK, Khaw P, Brooks S, Thompson JS, Huh WK, Mathews CA, Buck M, Suder A, Lad TE, Barani IJ, Holschneider CH, Van Dyk S, Quinn M, Rischin D, Monk BJ, Stockler MR. Adjuvant chemotherapy following chemoradiotherapy as primary treatment for locally advanced cervical cancer versus chemoradiotherapy alone (OUTBACK): an international, open-label, randomised, phase 3 trial. Lancet Oncol. 2023 May;24(5):468-482. Epub 2023 Apr 17. link to original article link to PMC article PubMed NCT01414608