Dana-Farber Cancer Institute, Boston, MA
Lauren Christine Harshman , Susanna J. Jacobus , Stephanie A. Mullane , Hope Feldman , Michelle S. Hirsch , Philip W. Kantoff , Toni K. Choueiri , Joaquim Bellmunt
Background: Neoadjuvant cisplatin-based chemo is the standard of care for muscle invasive UC. ddMVAC and GC are frequently used regimens but have not been directly compared. The choice is often based on physician preference and toxicity profile. We interrogated a pre-existing database of UC patients (pts) for differences in efficacy and toxicity among them. Methods: From 2007-2013, consecutive pts who had received presurgical chemo prior to primary tumor resection for muscle invasive, non-metastatic UC were identified. Tolerability, toxicity and efficacy were evaluated. Rates were calculated by regimen and compared using Fisher’s exact test. Disease-free survival (DFS) and overall survival (OS) were estimated using the Kaplan-Meier method and compared by regimen using logrank test. Cox regression estimated hazard ratios (HR) in univariate and adjusted models. Results: Of the96 patients eligible for analysis (GC: 40, ddMVAC: 56), 42% of GC pts had ≥cT3 and 23% had cN+ compared to 62% and 39% with ddMVAC. pCR rate was 18% for GC and 27% for ddMVAC (p=0.33). With a median follow-up of 28 mo., 2-yr OS probabilities were 59% [95% CI:(39-74)] on GC and 77%[95%CI:(60-87%)] on ddMVAC (p=0.1). Conclusions: Despite having more clinical ≥T3 and node positive disease at baseline, ddMVAC is at least as active as GC and achieved a numerically higher rate of pCRs/≤pT1 than GC in our cohort. No unexpected toxicities surfaced. Dose delays, discontinuations, and most selected toxicities appeared higher with GC. Neither DFS or OS significantly differed between the two regimens, however, there was a trend to greater benefit with ddMVAC.
ddMVAC (n=56) | GC (n=40) | |
---|---|---|
No. of cycles | 3 (5%), 4 (87%) | 3 (45%), 4 (45%) |
pT0 | 15 (27%) | 7 (18%) |
95% CI:16-40 | 95% CI: 7-33 | |
≤pT1 | 29 (52%) | 14 (35%) |
≤ | CI: 38-65 | CI: 21-52 |
Hospital Admissions | 10 (18%) | 10 (25%) |
Any Dose Reduction | 10 (18%) | 8 (20%) |
Any Dose Delay | 9 (16%) | 14 (35%) |
Discontinued for toxicity | 0 (0%) | 3 (7%) |
Nausea | 24 (42.9%) | 26 (65%) |
Diarrhea | 3 (5.4%) | 4 (10%) |
Mucositis | 17 (30.4%) | 1 (2.5%) |
Neurologic | 6 (10.7%) | 9 (22.5%) |
Neutropenia | 4 (7.1%) | 9 (22.5%) |
Thrombocytopenia | 1 (1.8%) | 5 (12.5%) |
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