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Poster display session

4309 - Phase II California Cancer Consortium Trial of Gemcitabine-Eribulin Combination (GE) In Cisplatin Ineligible Patients (pts) with Metastatic Urothelial Carcinoma (mUC): Efficacy Report (NCI-9653; 1UM1CA186717, NO1-CM-2011-00038)

Date

10 Sep 2017

Session

Poster display session

Topics

Cytotoxic Therapy;  Urothelial Cancers

Presenters

Sarmad Sadeghi

Citation

Annals of Oncology (2017) 28 (suppl_5): v295-v329. 10.1093/annonc/mdx371

Authors

S. Sadeghi1, S. Groshen2, R.A. Parikh3, A. Mortazavi4, T. Dorff1, C. Hoimes5, L. Doyle6, D.I. Quinn1, E. Newman7, P. Lara8

Author affiliations

  • 1 Oncology, University of Southern California Norris Comprehensive Cancer Center, 90033 - Los Angeles/US
  • 2 Preventive Medicine-biostatistics, University of Southern California, Keck School of Medicine, 90033 - Los Angeles/US
  • 3 Principal Investigator, University of Pittsburgh Medical Center, 15232 - Pittsburg/US
  • 4 Internal Medicine, James Cancer Hospital and Solove Research Institute, Columbus/US
  • 5 Hematology And Oncology, Case Western Reserve University and University Hospitals Seidman Cancer Center, 44106 - Cleveland/US
  • 6 Nci, National Cancer Institute, 22222 - Bethesda/US
  • 7 Oncology, City of Hope, 99999 - Duarte/US
  • 8 Medical Oncology, University of California Davis Cancer Center, 95817 - Sacramento/US
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Resources

Abstract 4309

Background

Cisplatin-based regimens are the mainstay of treatment (tx) for mUC. Unfortunately, pts with mUC are often elderly and have comorbid conditions that preclude cisplatin-based tx. This CTEP-sponsored trial seeks to assess the efficacy and tolerability of GE in this population.

Methods

A Simon 2 stage design was employed (7 + 14). To proceed to full accrual first stage required 2 or more confirmed responders- complete (CR) or partial (PR) response. To be a positive trial, 7 responders were required. Tx consisted of Gemcitabine 1gm/m2 and Eribulin 1.4mg/m2, both on Day (D) 1 and D8 of a 21-D cycle and continued until progression (PD) or unacceptable toxicities. Cisplatin ineligibility was defined as creatinine clearance (CrCl)

Results

Between 6/2015 and the report cutoff date of 5/2017, 24 eligible pts with a median age of 73 (range: 62-88) were enrolled. Demographics: 20 males, 4 females. ECOG performance status of 0/1/2 was seen in 11/11/2 pts. Sites of disease included: nodes 16, lungs 8, liver 7, bladder 5, bones 2. Median number of cycles was 3.5 (range 1-16). 2+ confirmed PRs in the first 7 pts allowed the trial to proceed to full accrual. Of 19 evaluable pts, 2 had a CR, 10 had a PR, 5 had SD and 1 had PD. The objective response rate (ORR) was 63%. Overall survival (OS) 14.9 months (5.6, 21.9+) and progression free survival (PFS) was 6.9 months (5.3, 16.1+). Duration of response (DOR) was 4.6 months (range: 0.5, 15.0). Among the first 21 pts 7 had a PR and 2 had a CR and 5 were inevaluable for response, with an ORR of 43%. All 24 pts were evaluable for toxicities; the most common any grade toxicities included fatigue 83%, neutropenia 75%, anemia 63%, alopecia 50%, elevated AST 46%, constipation and nausea 42% each and thrombocytopenia 36%.

Conclusions

GE exceeded the threshold for efficacy in this trial. The endpoints of ORR, OS and PFS compare favorably to the commonly used regimens in this setting such as gemcitabine-carboplatin with a confirmed ORR of 36.1% and OS of 9.3 months. These data support further development of this combination in pre-and post immunotherapy settings.

Clinical trial identification

NCI-9653

Legal entity responsible for the study

NCI

Funding

None

Disclosure

All authors have declared no conflicts of interest

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