Phase II study of eribulin mesylate, a halichondrin B analog, in patients with metastatic breast cancer previously treated with an anthracycline and a taxane.

PURPOSE: Eribulin mesylate (E7389), a nontaxane microtubule dynamics inhibitor, is a structurally simplified, synthetic analog of the marine natural product halichondrin B. This open-label, single-arm, phase II study evaluated efficacy and tolerability of eribulin in heavily pretreated patients with metastatic breast cancer (MBC). METHODS: MBC patients who were previously treated with an anthracycline and a taxane received eribulin mesylate (1.4 mg/m(2)) as a 2- to 5-minute intravenous (IV) infusion on days 1, 8, and 15 of a 28-day cycle. Because of neutropenia (at day 15), an alternative regimen of eribulin on days 1 and 8 of a 21-day cycle was administered. The primary end point was overall response rate. RESULTS: Of the 103 patients treated, the median number of prior chemotherapy regimens was four (range, one to 11 regimens). In the per-protocol population (n = 87), eribulin achieved an independently reviewed objective response rate (all partial responses [PRs]) of 11.5% (95% CI, 5.7 to 20.1) and a clinical benefit rate (PR plus stable disease > or = 6 months) of 17.2% (95% CI, 10.0 to 26.8). The median duration of response was 171 days (5.6 months; range, 44 to 363 days), the median progression-free survival was 79 days (2.6 months; range, 1 to 453 days), and the median overall survival was 275 days (9.0 months; range, 15 to 826 days). The most common drug-related grades 3 to 4 toxicities were as follows: neutropenia, 64%; leukopenia, 18%; fatigue, 5%; peripheral neuropathy, 5%; and febrile neutropenia, 4%. CONCLUSION: Eribulin demonstrated activity with manageable tolerability (including infrequent grade 3 and no grade 4 neuropathy) in heavily pretreated patients with MBC when dosed as a short IV infusion on days 1 and 8 of a 21-day cycle.

Hospice utilization by male and female cancer patients in an end-of-life transition program.

OBJECTIVE: to determine if there were sex differences in patients' use of hospice services in a regional cancer center in Texas from 1998 to 2000. METHODS: A quality-of-life program for patients with cancer that included an end-of-life component was initiated in 1998 at a regional cancer center. The records of 1057 female and 986 male cancer patients who died from 1998 to 2000 were reviewed. Data on demographics, use of hospice care, length of stay, and location at time of referral were collected and analyzed. RESULTS: Hospice utilization increased in women (47% v 64%; p<.001) and men (53% v 66%; p<.001) who died of cancer from 1998 to 2000. Length of stay (LOS) in hospice did not change for women, but decreased significantly for men over that time (31 days v 14 days, p<.001). The number of men with stays of 14 days or less increased significantly (30% v 53%, p<.001). Subjects whose LOS were less than 14 days were more likely to be hospital inpatients at time of referral. CONCLUSIONS: The institution of a targeted end-of-life program was associated with increased utilization of hospice services in women with cancer at this regional cancer center. Length of stay in hospice was longer for women than men, and more men had very short (less than 14 day) stays. Hospice referrals from outpatient settings were associated with longer LOS.