Abstract 651P
Background
Triplet DCF (docetaxel, cisplatin and 5-fluorouracil) and doublet CP/CF (carboplatin and paclitaxel/cisplatin and 5-fluorouracil) regimens were prospectively evaluated in advanced squamous anal cell carcinoma (SCCA), and validated as standard treatments. Even though the high efficacy and good tolerance of DCF regimen were confirmed in 3 independent prospective trials, doublet CP regimen is still recommended in several guidelines based in its better safety profile with similar efficacy compared to CF regimen.
Methods
We performed a propensity score-adjusted method with inverse probability of treatment weighted (IPTW) and matched case control (MCC) comparison among patients with metastatic or non-resectable locally advanced recurrent SCCA, treated with chemotherapy as first-line regimen. The primary endpoint was the overall survival (OS), and the secondary endpoint was the progression-free survival (PFS).
Results
247 patients were included for analysis. 154 patients received DCF and 93 patients received a doublet regimen. Patients’ characteristics and outcomes in both groups were comparable to published data. The median OS was 32.3 months with DCF and 18.3 months with doublet regimens (HR 0.53, 95%CI 0.38-0.74; p=0.0001), and the median PFS was 11.2 months with DCF versus 7.6 months with doublet regimens (HR 0.53, 95%CI 0.39-0.73; p<0.0001). The hazard ratios by IPTW and MCC analyses were 0.411 and 0.406 for OS, and 0.466 and 0.438 for PFS (Table). Table: 651P
Multivariate Cox analyses for OS and PFS in propensity score matched population and with IPTW weighted method
Matched analysis (n=154) | IPTW analysis (n=247) | |||||
HR | 95%CI | P | HR | 95%CI | P | |
OS | 0.406 | 0.261-0.632 | <0.0001 | 0.411 | 0.324-0.521 | <0.0001 |
PFS | 0.438 | 0.298-0.644 | <0.0001 | 0.466 | 0.376-0.576 | <0.0001 |
Conclusions
The triplet DCF regimen provides a high and significant benefit in OS and PFS over doublet regimens, and can be considered as upfront treatment for eligible patients with advanced SCCA.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
S. Kim.
Funding
Has not received any funding.
Disclosure
T. André: Financial Interests, Personal, Advisory Board, Advisory Board on February 12, 2021: Astellas pharma; Financial Interests, Personal, Advisory Board, Advisory Board on February 2021: Kaleido Biosciences; Financial Interests, Personal, Invited Speaker, and advisory board: Amgen; Financial Interests, Personal, Invited Speaker, Invited speaker in a symposium december 2020: AstraZeneca; Financial Interests, Personal, Advisory Board, and consultant fees and consultant contract: Bristol Myers Squibb; Financial Interests, Personal, Advisory Board, Advisory board in Janaury 2020 : Clovis; Financial Interests, Personal, Advisory Board, Advisory board in january 2020: Gritstone Oncology; Financial Interests, Personal, Advisory Board: Haliodx; Financial Interests, Personal, Advisory Board, and consultant fees/consultant contract and invited speaker: MSD Oncology; Financial Interests, Personal, Invited Speaker, and other: Pierre Fabre; Financial Interests, Personal, Invited Speaker, in an symposium in 2020: Roche; Financial Interests, Personal, Invited Speaker, in a meeting in 2019: Ventana; Financial Interests, Personal, Invited Speaker, In a educational meeting in 2019: Sanofi; Financial Interests, Personal, Advisory Board, in a symposium in 2020: Servier; Financial Interests, Personal, Expert Testimony, Consultant with personal fees and invited speaker: Servier; Financial Interests, Personal, Advisory Board, in 2019: GSK; Financial Interests, Personal, Invited Speaker, in 2020 and 2021: GSK; Financial Interests, Personal, Invited Speaker, Virtual symposuimLecture: 1 MSI-H CRC: Implementation of Immunotherapy in clinical practice (30 minutes) – (this will be pre-recorded)Q&A – Live Q&A – (10 minutes) (on July 2, 2021): MSD Oncology; Financial Interests, Personal, Invited Speaker, June 2022 : Sanofi; Financial Interests, Personal, Advisory Board, Contract: Merck & Co., Inc, Gritstone Oncologie; Financial Interests, Personal, Advisory Board, Contrat 2019 , 2020 , 2021 , 2022 : Bristol Myers Squibb; Financial Interests, Personal, Invited Speaker, June 2022 during ESMO GI meeting: Seagen; Financial Interests, Personal, Invited Speaker, Contract of consulting 2021 and 2022: MSD Oncology; Financial Interests, Personal, Advisory Board, September 2022 : GSK, Seagen; Financial Interests, Personal, Invited Speaker, Contract of consulting 2022 and 2023: GSK; Financial Interests, Personal, Invited Speaker, Contract of consulting 2022: Nordic Pharma; Financial Interests, Personal, Invited Speaker, October 2022 : Merck Serono; Financial Interests, Personal, Other, Educational in 2022: Roche; Financial Interests, Personal, Other, Contract of consulting 2020, 2021, 2022: Servier; Financial Interests, Institutional, Other, Investigator and scientific comitee president: Gercor Academic group; Financial Interests, Institutional, Invited Speaker, PI Garnet study: GSK; Financial Interests, Institutional, Invited Speaker, Keynote 164 and 171 and 811 and C08: MSD; Financial Interests, Institutional, Invited Speaker, Bristol Myers Squibb CA209-8HW, Bristol Myers Squibb CA209-142, Bristol Myers Squibb CA209-577: Bristol Myers Squibb; Financial Interests, Institutional, Invited Speaker, SPOTLIGHT study: Astellas; Financial Interests, Personal, Invited Speaker, and international PI (trial chair Solstice study): Servier; Financial Interests, Personal, Invited Speaker, MOUNTAINEER and MOUNTAINEER-03 study (PI for France): Seagen; Non-Financial Interests, , Invited Speaker, Vice President: Gercor group; Non-Financial Interests, , Invited Speaker, Member of scientific commitee: ARCAD Foundation . O. Bouche: Financial Interests, Personal, Advisory Board: Amgen, Merck, Apmonia Therapeutics, Deciphera; Financial Interests, Personal, Invited Speaker: Servier, Pierre Fabre, Bayer. C. de la Fouchardiere: Financial Interests, Personal, Advisory Board: Merck, Roche, Lilly, Bayer, Amgen, MSD, Servier, Pierre Fabre Oncologie, Bristol Myers Squibb, Incyte, Daiichi Sankyo; Financial Interests, Personal, Invited Speaker: Ipsen, Eisai, Servier, MSD, Daiichi Sankyo; Financial Interests, Institutional, Invited Speaker: Pierre Fabre Oncologie, Servier; Non-Financial Interests, Principal Investigator: Amgen, Daiichi Sankyo, MSD. J. Taieb: Financial Interests, Personal, Advisory Board: MSD, Roche, Merck, Servier, Pierre Fabre, Amgen, Bristol Myers Squibb, Novartis; Financial Interests, Personal, Invited Speaker: Amgen, Bristol Myers Squibb, Merck, MSD, Novartis, Pierre Fabre, Roche, Servier; Non-Financial Interests, Leadership Role, President of the scientific committee of the ARCAD foundation until end 2022: ARCAD Foundation; Non-Financial Interests, Leadership Role, Chair of the ARCAD pancreas research group: ARCAD Foundation; Non-Financial Interests, Leadership Role, Member of the administrative council, the scientific committee, the executive board and responsible for the international relationships /partnership for FFCD in the prodige intergroup: Federation Francophone de Cancerologie Digestive (FFCD). All other authors have declared no conflicts of interest.
Resources from the same session
638P - Stereotactic ablative radiotherapy combined with fruquintinib and tislelizumab in metastatic colorectal cancer: Preliminary findings from a single-arm, prospective phase II trial (RIFLE)
Presenter: Yajiie Chen
Session: Poster session 11
641P - Phase I/II study of the EP4 antagonist CR6086 combined with the anti-PD-1 balstilimab in mismatch-repair-proficient and microsatellite stable (pMMR/MSS) chemorefractory metastatic colorectal cancer (mCRC)
Presenter: Filippo Pietrantonio
Session: Poster session 11
642P - A phase I dose escalation study of GCC19CART: A novel CoupledCAR therapy for subjects with metastatic colorectal cancer
Presenter: Jiuwei Cui
Session: Poster session 11
643P - A phase Ib/IIa study to assess the safety, tolerability, pharmacokinetics, and antitumor activity of YYB101, hepatocyte growth factor neutralizing humanized monoclonal antibody, in combination with irinotecan in metastatic or recurrent colorectal cancer patients (NOV110501-201)
Presenter: Yongjun Cha
Session: Poster session 11
645P - A phase Ib dose escalation study of binimetinib plus mFOLFIRI in patients with metastatic RAS mutated colorectal cancer
Presenter: Vaia Florou
Session: Poster session 11
646P - Phase Ib/II study of ompenaclid (RGX-202-01), afirst-in-class oral inhibitor of the creatine transporter SLC6A8, in combination with FOLFIRI and bevacizumab (BEV) in RAS mutated (RASm) second-line (2L) advanced/metastatic colorectal cancer (mCRC)
Presenter: Andrew Hendifar
Session: Poster session 11
647P - Patient-derived xenograft approach to explore differential responses to diet dependent on genotypic or phenotypic characteristics of colorectal cancer
Presenter: Giulia Rizzo
Session: Poster session 11