Academic Unit of Medical Oncology, IRCCS San Martino University Hospital - IST National Cancer Research Institute, Genoa, Italy
Milena Bruzzone , Chiara Dellepiane , Elisa Bo , Alessia Cavo , Flavio Giannelli , Maria Grazia Centurioni , Maurizio Cosso , Franco Alessandri , Valerio Gaetano Vellone , Rodolfo Sirito , Elisa Zanardi , Giulia Buzzatti , Carlo Messina , Carlo Cattrini , Claudio Gustavino , Francesco Boccardo
Background: concurrent CT-RT is the standard treatment for LACC. Currently weekly low dose Cisplatin based CT is the radio-sensitizing treatment suggested. Our single-center, prospective, single-arm, phase II study evaluates activity and toxicity of C-P regimen administered every 3 weeks for 4 courses, at cytotoxic dose, with concurrent RT in LACC or LRCC patients (pts). Methods: Inclusion criteria: LACC (FIGO stage IB2–IVB) or LRCC after hysterectomy, ECOG 0-1, Age 18-75. Cisplatin (75 mg/m2) and Paclitaxel (175 mg/m2) every 21 days, for 4 courses were administered with concurrent RT (50 Gy, 25 courses) and high-dose rate brachytherapy (6 Gy, 3 courses). Pelvic RT started 2 weeks after CT cycle 1, 1st brachytherapy insertion was carried out during CT cycle 4. Overall Survival (OS) and Progression Free Survival (PFS) were evaluated by Kaplan-Meier method, Response by RECIST 1.1, toxicity by NCI CTC. Simon's optimal two stage design was applied: P0 = 20% (complete response (CR) < 20% was of no interest), P1 = 40%; for a power of 80% 13 pts had to be enrolled into the 1st stage (α = 0.05, ß = 0.20). Results: Between 2000 and 2014, 65 pts were enrolled: 57 LACC and 8 LRCC after hysterectomy. 2 pts died during the treatment, due to causes not tumor/therapy related: one of these pts was not evaluable for response but everyone was considered for toxicity and survival analysis. Among 64 pts evaluable for response: 55 CR (84.62%), 8 Partial Response (PR) (12.31%), 1 Stable Disease (1.54%) were observed, Response Rate (RR = CR+PR) 96.92% (95% CI: 92.71%-100%). Median follow up: 58 months (2-184), PFS and OS are 66.6% and 67.3% respectively at 180 months from the study start. 2 pts died during the follow up due to second primary cancers. A grade (G) 4 toxicity was reported (leukopenia), G3 toxicities detected were: proctitis (24.61%), leukopenia (15.38%), anemia (15.38%), diarrhea (13.85%), emesis (6.15%), cystitis (6.15%), thrombocytopenia (1.54%). Conclusions: At a long term follow up Cisplatin-Paclitaxel regimen with concurrent RT shows an important activity and a good safety profile in LACC or LRCC patient.
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