Unknown

Dataset Information

0

Neoadjuvant dose-dense methotrexate, vinblastine, doxorubicin, and cisplatin with pegfilgrastim support in muscle-invasive urothelial cancer: pathologic, radiologic, and biomarker correlates.


ABSTRACT: PURPOSE:In advanced urothelial cancer, treatment with dose-dense methotrexate, vinblastine, doxorubicin, and cisplatin (ddMVAC) results in a high response rate, less toxicity, and few dosing delays. We explored the efficacy and safety of neoadjuvant ddMVAC with pegfilgrastim support in muscle-invasive urothelial cancer (MIUC). PATIENTS AND METHODS:Patients with cT2-cT4, N0-1, M0 MIUC were enrolled. Four cycles of ddMVAC were administered, followed by radical cystectomy. The primary end point was pathologic response (PaR) defined by pathologic downstaging to ? pT1N0M0. The study used Simon's optimal two-stage design to evaluate null and alternative hypotheses of PaR rate of 35% versus 55%. Secondary end points included toxicity, disease-free survival (DFS), radiologic response (RaR), and biomarker correlates, including ERCC1. RESULTS:Between December 2008 and April 2012, 39 patients (cT2N0, 33%; cT3N0, 18%; cT4N0, 3%; cT2-4N1, 43%; unspecified, 3%) were enrolled. Median follow-up was 2 years. Overall, 49% (80% CI, 38 to 61) achieved PaR of ? pT1N0M0, and we concluded this regimen was effective. High-grade (grade ? 3) toxicities were observed in 10% of patients, with no neutropenic fevers or treatment-related death. One-year DFS was 89% versus 67% for patients who achieved PaR compared with those who did not (hazard ratio [HR], 2.6; 95% CI, 0.8 to 8.1; P = .08) and 86% versus 62% for patients who achieved RaR compared with those who did not (HR, 4.1; 95% CI, 1.3 to 12.5; P = .009). We found no association between serum tumor markers or ERCC1 expression with response or survival. CONCLUSION:In patients with MIUC, neoadjuvant ddMVAC was well tolerated and resulted in significant pathologic and radiologic downstaging.

SUBMITTER: Choueiri TK 

PROVIDER: S-EPMC7057274 | biostudies-literature | 2014 Jun

REPOSITORIES: biostudies-literature

altmetric image

Publications

Neoadjuvant dose-dense methotrexate, vinblastine, doxorubicin, and cisplatin with pegfilgrastim support in muscle-invasive urothelial cancer: pathologic, radiologic, and biomarker correlates.

Choueiri Toni K TK   Jacobus Susanna S   Bellmunt Joaquim J   Qu Angela A   Appleman Leonard J LJ   Tretter Christopher C   Bubley Glenn J GJ   Stack Edward C EC   Signoretti Sabina S   Walsh Meghara M   Steele Graeme G   Hirsch Michelle M   Sweeney Christopher J CJ   Taplin Mary-Ellen ME   Kibel Adam S AS   Krajewski Katherine M KM   Kantoff Philip W PW   Ross Robert W RW   Rosenberg Jonathan E JE  

Journal of clinical oncology : official journal of the American Society of Clinical Oncology 20140512 18


<h4>Purpose</h4>In advanced urothelial cancer, treatment with dose-dense methotrexate, vinblastine, doxorubicin, and cisplatin (ddMVAC) results in a high response rate, less toxicity, and few dosing delays. We explored the efficacy and safety of neoadjuvant ddMVAC with pegfilgrastim support in muscle-invasive urothelial cancer (MIUC).<h4>Patients and methods</h4>Patients with cT2-cT4, N0-1, M0 MIUC were enrolled. Four cycles of ddMVAC were administered, followed by radical cystectomy. The primar  ...[more]

Similar Datasets

| S-EPMC4775435 | biostudies-literature
| S-EPMC8656312 | biostudies-literature
| S-EPMC6071437 | biostudies-literature
| S-EPMC4050203 | biostudies-literature
| S-EPMC3255563 | biostudies-literature
| S-EPMC5018246 | biostudies-literature
| S-EPMC7832124 | biostudies-literature
| S-EPMC4963434 | biostudies-literature
| S-EPMC7870853 | biostudies-literature
| S-EPMC7681778 | biostudies-literature