ABSTRACT
OBJECTIVES: Metastatic squamous cell carcinoma anal cancer (SCCA) is rare. Prospective data recommends front-line platinum doublet combinations and second-line anti-programmed death-1 therapy. Standard therapy beyond these treatments are currently unknown. We evaluated anti-EGFR monoclonal antibody (mAb) outcomes in metastatic SCCA. METHODS: Metastatic SCCA patients given anti-EGFR mAb from Oct 2011-May 2018 were included. Primary endpoints included best response, progression-free survival, and overall survival. RESULTS: 56 patients were evaluated with a median of one prior therapy. Most patients (~90%) received anti-EGFR mAbs with chemotherapy. Response rate (any response) was 41%. Median PFS was 4.3 months with a median OS of 16 M. Seven patients with disease control proceeded onto maintenance therapy (anti-EGFR mAb ± a fluoropyrimidine) with a median PFS of 13.8 M. Next generation sequencing of 16 pts (28%) showed 4 pts had a PIK3CA mutation with 3 of these 4 patients demonstrating progression on initial restaging. CONCLUSION: Our analysis suggests anti-EGFR mAb therapy with chemotherapy provides clinical benefit in previously treated metastatic SCCA. Our maintenance therapy and the role of PIK3CA MT outcomes were thought-provoking. EXPERT OPINION: Metastatic SCCA patients have limited options; therefore, anti-EGFR mAbs may provide benefit in the treatment armamentarium and should be further explored.
Subject(s)
Antibodies, Monoclonal/administration & dosage , Anus Neoplasms/drug therapy , Carcinoma, Squamous Cell/drug therapy , ErbB Receptors/antagonists & inhibitors , Adult , Aged , Antibodies, Monoclonal/pharmacology , Antineoplastic Agents/administration & dosage , Antineoplastic Agents/pharmacology , Anus Neoplasms/genetics , Anus Neoplasms/pathology , Carcinoma, Squamous Cell/genetics , Carcinoma, Squamous Cell/pathology , Class I Phosphatidylinositol 3-Kinases/genetics , Female , Follow-Up Studies , High-Throughput Nucleotide Sequencing , Humans , Male , Middle Aged , Neoplasm Metastasis , Neoplasm Recurrence, Local , Progression-Free Survival , Retrospective Studies , Survival RateABSTRACT
The cure fraction models are usually used to model lifetime time data with long-term survivors. In the present article, we introduce a Bayesian analysis of the four-parameter generalized modified Weibull (GMW) distribution in presence of cure fraction, censored data and covariates. In order to include the proportion of "cured" patients, mixture and non-mixture formulation models are considered. To demonstrate the ability of using this model in the analysis of real data, we consider an application to data from patients with gastric adenocarcinoma. Inferences are obtained by using MCMC (Markov Chain Monte Carlo) methods.
Subject(s)
Models, Theoretical , Stomach Neoplasms/pathology , Bayes Theorem , HumansABSTRACT
BACKGROUND: Adjuvant chemoradiotherapy (CRT) is the standard treatment in Western countries for gastric cancer patients submitted to curative resection. However, the role of adjuvant CRT in gastric cancer treated with D2 lymphadenectomy has not been well defined. METHODS: We conducted a retrospective study in patients with stage II to IV gastric adenocarcinoma with no distant metastases, who underwent curative resection with D2 lymphadenectomy between January 2002 and December 2007. The present study compared the 3-year overall survival of two treatments (adjuvant CRT according to the INT 0116 trial versus resection alone). Survival curves were estimated by the Kaplan-Meier method and compared with a log-rank test. Multivariate analysis of prognostic factors was performed by the Cox proportional hazards model. RESULTS: A total of 185 patients were included, 104 patients (56 %) received adjuvant CRT and 81 received resection alone. The 3-year overall survival was 64.4 % in the CRT group and 61.7 % in the resection-alone group (p: 0.415). However, according to the Cox proportional hazards model, adjuvant CRT was a prognostic factor for 3-year overall survival (hazard ratio [HR] 0.46, 95 % confidence interval [CI] 0.26-0.82, p: 0.008). CONCLUSIONS: In the present study, adjuvant CRT was associated with a lower risk of death over a 3-year period in gastric cancer patients treated with D2 lymphadenectomy.
