Cisplatin (C)-paclitaxel (P) chemotherapy (CT) regimen with concurrent radiotherapy (RT) in local advanced (LACC) or recurrent (LRCC) cervical cancer: 14 year-results of a phase II study.

Authors

null

Milena Bruzzone

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

Organizations

Academic Unit of Medical Oncology, IRCCS San Martino University Hospital - IST National Cancer Research Institute, Genoa, Italy, University of Genoa, Department of Internal Medicine, School of Medicine, Genoa, Italy, Department of Radiation Oncology IRCCS San Martino University Hospital - IST National Cancer Research Institute, Genova, Italy, Unit of Obstetrics and Gynecology, IRCCS San Martino University Hospital - IST National Cancer Research Institute, Genova, Italy, Department of Radiology IRCCS San Martino University Hospital - IST National Cancer Research Institute, Genova, Italy, University of Genoa, Anatomic Pathology Unit, Department of Surgical Sciences and Integrated Diagnostics (DISC), Genova, Italy, Obstetric Gynecology OEI, Genoa, Italy

Research Funding

Other

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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Abstract Details

Meeting

2016 ASCO Annual Meeting

Session Type

Poster Session

Session Title

Gynecologic Cancer

Track

Gynecologic Cancer

Sub Track

Cervical Cancer

Citation

J Clin Oncol 34, 2016 (suppl; abstr 5529)

DOI

10.1200/JCO.2016.34.15_suppl.5529

Abstract #

5529

Poster Bd #

352

Abstract Disclosures