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Phase II California Cancer Consortium Trial of Gemcitabine-Eribulin Combination in Cisplatin-Ineligible Patients With Metastatic Urothelial Carcinoma: Final Report (NCI-9653).

Publication ,  Journal Article
Sadeghi, S; Groshen, SG; Tsao-Wei, DD; Parikh, R; Mortazavi, A; Dorff, TB; Kefauver, C; Hoimes, C; Doyle, L; Quinn, DI; Newman, E; Lara, PN
Published in: J Clin Oncol
October 10, 2019

PURPOSE: Patients with metastatic urothelial carcinoma are often ineligible for cisplatin-based treatments. A National Cancer Institute Cancer Therapy Evaluation Program-sponsored trial assessed the tolerability and efficacy of a gemcitabine-eribulin combination in this population. METHODS: Patients with treatment-naïve advanced or recurrent metastatic urothelial carcinoma of the bladder, ureter, or urethra not amenable to curative surgery and not candidates for cisplatin-based therapy were eligible. Cisplatin ineligibility was defined as creatinine clearance less than 60 mL/min (but ≥ 30 mL/min), grade 2 neuropathy, or grade 2 hearing loss. Treatment was gemcitabine 1,000 mg/m2 intravenously followed by eribulin 1.4 mg/m2, both on days 1 and 8, repeated in 21-day cycles until progression or unacceptable toxicity. A Simon two-stage phase II trial design was used to distinguish between Response Evaluation Criteria in Solid Tumors, version 1.1 objective response rates of 20% versus 50%. RESULTS: Between June 2015 and March 2017, 24 eligible patients with a median age of 73 years (range, 62 to 88 years) underwent therapy. Performance status of 0, 1, or 2 was seen in 11, 11, and two patients, respectively. Sites of disease included: lymph nodes, 16; lungs, nine; liver, seven; bladder, five; bones, two. Median number of cycles received was four (range, one to 16). Of 24 patients, 12 were confirmed responders; the observed objective response rate was 50% (95% CI, 29% to 71%). Median overall survival was 11.9 months (95% CI, 5.6 to 20.4 months), and median progression-free survival was 5.3 months (95% CI, 4.5 to 6.7 months). The most common treatment-related any-grade toxicities were fatigue (83% of patients), neutropenia (79%), anemia (63%), alopecia (50%), elevated AST (50%), and constipation, nausea, and thrombocytopenia (42% each). CONCLUSION: Gemcitabine-eribulin treatment response and survival for cisplatin-ineligible patients compare favorably to other regimens. Additional research is needed.

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Published In

J Clin Oncol

DOI

EISSN

1527-7755

Publication Date

October 10, 2019

Volume

37

Issue

29

Start / End Page

2682 / 2688

Location

United States

Related Subject Headings

  • Urologic Neoplasms
  • Urinary Bladder Neoplasms
  • Urethral Neoplasms
  • Ureteral Neoplasms
  • Treatment Outcome
  • Oncology & Carcinogenesis
  • Neoplasm Recurrence, Local
  • Neoplasm Metastasis
  • Middle Aged
  • Male
 

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Sadeghi, S., Groshen, S. G., Tsao-Wei, D. D., Parikh, R., Mortazavi, A., Dorff, T. B., … Lara, P. N. (2019). Phase II California Cancer Consortium Trial of Gemcitabine-Eribulin Combination in Cisplatin-Ineligible Patients With Metastatic Urothelial Carcinoma: Final Report (NCI-9653). J Clin Oncol, 37(29), 2682–2688. https://doi.org/10.1200/JCO.19.00861
Sadeghi, Sarmad, Susan G. Groshen, Denice D. Tsao-Wei, Rahul Parikh, Amir Mortazavi, Tanya B. Dorff, Cheryl Kefauver, et al. “Phase II California Cancer Consortium Trial of Gemcitabine-Eribulin Combination in Cisplatin-Ineligible Patients With Metastatic Urothelial Carcinoma: Final Report (NCI-9653).J Clin Oncol 37, no. 29 (October 10, 2019): 2682–88. https://doi.org/10.1200/JCO.19.00861.
Sadeghi S, Groshen SG, Tsao-Wei DD, Parikh R, Mortazavi A, Dorff TB, et al. Phase II California Cancer Consortium Trial of Gemcitabine-Eribulin Combination in Cisplatin-Ineligible Patients With Metastatic Urothelial Carcinoma: Final Report (NCI-9653). J Clin Oncol. 2019 Oct 10;37(29):2682–8.
Sadeghi, Sarmad, et al. “Phase II California Cancer Consortium Trial of Gemcitabine-Eribulin Combination in Cisplatin-Ineligible Patients With Metastatic Urothelial Carcinoma: Final Report (NCI-9653).J Clin Oncol, vol. 37, no. 29, Oct. 2019, pp. 2682–88. Pubmed, doi:10.1200/JCO.19.00861.
Sadeghi S, Groshen SG, Tsao-Wei DD, Parikh R, Mortazavi A, Dorff TB, Kefauver C, Hoimes C, Doyle L, Quinn DI, Newman E, Lara PN. Phase II California Cancer Consortium Trial of Gemcitabine-Eribulin Combination in Cisplatin-Ineligible Patients With Metastatic Urothelial Carcinoma: Final Report (NCI-9653). J Clin Oncol. 2019 Oct 10;37(29):2682–2688.

Published In

J Clin Oncol

DOI

EISSN

1527-7755

Publication Date

October 10, 2019

Volume

37

Issue

29

Start / End Page

2682 / 2688

Location

United States

Related Subject Headings

  • Urologic Neoplasms
  • Urinary Bladder Neoplasms
  • Urethral Neoplasms
  • Ureteral Neoplasms
  • Treatment Outcome
  • Oncology & Carcinogenesis
  • Neoplasm Recurrence, Local
  • Neoplasm Metastasis
  • Middle Aged
  • Male