BACKGROUND: Rescue of patients who fail to be cured after 2 or 3 chemotherapy combinations (including high-dose chemotherapy [HDCT]) or whose disease is refractory to cisplatin is still an unmet need.
We assessed the efficacy of a triple-combination chemotherapy in the salvage setting, beyond second-line regimens.
PATIENTS AND METHODS: We retrospectively reviewed institutional data on consecutive patients who received paclitaxel 80 mg/m2 intravenously (IV), cisplatin 50 mg/m2 IV, and gemcitabine 800 mg/m2 IV on days 1 and 8 every 3 weeks for a maximum of 8 administrations, followed by surgery. Response, survival (progression-free survival [PFS] and overall survival [OS]), and safety/toxicity outcomes were the end points. The Kaplan-Meier method was used for survival estimates, and multiple Cox regression models were used to analyze the prognostic factors.
RESULTS: Seventy-five patients were treated from April 1999 to July 2011. Eight complete responses (CR, 10.7%), 29 partial responses with normal markers (PRm-, 38.7%), and 13 cases of incomplete response/stable disease were recorded, for a major response rate (CR + PRm-) of 49%. Thirty-three patients (44%) underwent surgery, which was radical in 14 cases (42.4%). Two-year PFS was 14.8% (95% confidence interval [CI], 8.5%-25.8%), whereas 2-year OS was 29.5% (95% CI, 20.3%-42.7%). Five-year OS in disease-free patients (no evidence of disease) was 60.3% (95% CI, 42.2%-86.2%), and median OS between patients with and without evidence of disease was significantly different (71 [interquartile range {IQR}, 14-116] vs. 12.5 [IQR, 8-19] months with a 6-month landmark analysis; P = .0019).
CONCLUSION: TPG is an effective combination, and best results were achieved if a radical clearance of residual disease could be accomplished. A randomized comparison with dose-intensified regimens is advisable.
Written by:
Necchi A, Nicolai N, Mariani L, Lo Vullo S, Giannatempo P, Raggi D, Farè E, Piva L, Biasoni D, Catanzaro M, Torelli T, Stagni S, Milani A, Gianni AM, Salvioni R. Are you the author?
Department of Medical Oncology, Medical Oncology 2 Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
Reference: Clin Genitourin Cancer. 2013 Oct 23. pii: S1558-7673(13)00195-X.
doi: 10.1016/j.clgc.2013.07.005
PubMed Abstract
PMID: 24161525
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