Eribulin Mesylate as Third or Subsequent Line Chemotherapy for Elderly Patients with Locally Recurrent or Metastatic Breast Cancer: A Multicentric Observational Study of GIOGer (Italian Group of Geriatric Oncology)-ERIBE.

BACKGROUND: Metastatic breast cancer (MBC) is highly prevalent in middle-aged or elderly patients. Eribulin is a nontaxane microtubule inhibitor, approved for the treatment of pretreated MBC. This multicentric study (sponsored by GIOGer, Italian Group for Geriatric Oncology) was designed to assess the efficacy and tolerability of eribulin, according to parameters usually used in geriatric oncology. SUBJECTS, MATERIALS, AND METHODS: An observational study was conducted on 50 consecutive elderly patients with MBC. The primary endpoint was to evaluate the change in items score of comprehensive geriatric assessment (CGA) and health-related quality of life (HRQL). Italian versions of the CGA and HRQL questionnaires were administered at baseline, before the third and fifth cycles, and then every three cycles until treatment discontinuation. Secondary endpoints were efficacy and safety. RESULTS: Overall, both EQ-5D scores and EQ-5D-3 L visual analogic scale did not significantly change from baseline; the percentage of subjects without problems doing usual activities tended to decrease during treatment (p for linear trend .018), and the percentage of patients with minor problems performing usual activities tended to increase (p for linear trend.012). Among CGA items, Instrumental Activities of Daily Living tended to decrease during treatment and Geriatric Depression Scale tended to increase. After 12 months follow-up, 24 patients (out of 47) showed clinical benefits; median progression-free survival was 4.49 months (2.10-10.33) and median OS was 7.31 months (3.70-14.03). The treatment was associated with mild toxicity. CONCLUSION: Eribulin treatment preserved quality of life and geriatric parameters included in the CGA, except for instrumental functioning and geriatric depression, in elderly patients with MBC. IMPLICATIONS FOR PRACTICE: A collaboration between oncologist and geriatric specialists is essential in the management of patients with metastatic breast cancer, who are frequently elderly or frail. The assessment of geriatric parameters in the decision-making process can contribute to direct toward the most appropriate therapeutic plan and preserve the quality of life of patients. Eribulin does not seem to affect quality of life or worsen the overall geriatric status; therefore, it can be considered a suitable option for elderly patients with metastatic breast cancer.

Prostate-specific antigen growth rate constant after first-line cytotoxic chemotherapy in metastatic castration-resistant prostate cancer: a monoinstitutional experience.

OBJECTIVE: Validation in clinical practice, after first-line chemotherapy (CT) of metastatic castration-resistant prostate cancer (PC), of prostate-specific antigen growth rate constant logarithm (PSA-G), calculated by a formula developed by Stein et al. in comparison with PSA decrease (PSA-D), calculated as recommended by PCWG2. PATIENTS AND METHODS: This study is a retrospective monoinstitutional assessment of PSA-G and PSA-D after 12 weeks from the beginning of first-line cytotoxic CT in 49 patients with metastatic castration-resistant PC treated from 2006 to 2011, and whose pre-CT PSA and post-CT PSA determinations have been measured at specific time points. The 12-week PSA was measured at 80 to 91 days from the beginning of CT. RESULTS: PSA-G exhibited a significant correlation with overall survival by Mann-Whitney U test and by linear regression, whereas PSA-D did only at the first test. After multivariate analysis, PSA-G was the only posttreatment measure to predict overall survival. CONCLUSION: PSA-G appears a reliable surrogate end point after first-line cytotoxic CT outside of clinical trials. A cutoff value of PSA-G post-CT higher than-2.4 could be considered suggestive for moving to another treatment.

CA125-related measures of tumor kinetics and outcome of patients with recurrent ovarian cancer receiving chemotherapy: a retrospective evaluation.

OBJECTIVE: Defining the reliability of cancer antigen-125-related kinetics criteria versus Gynecologic Cancer Inter Group criteria in predicting the tumor outcome after chemotherapy in patients with recurrent ovarian cancer. METHODS: A retrospective monoinstitutional assessment of CA125-related versus Gynecologic Cancer Inter Group-related parameters was performed after cytotoxic chemotherapy in patients with metastatic ovarian cancer treated from 2006 to 2011. A correlation analysis between the response and progression measurements has been performed, and the outcome has been reported. RESULTS: Among 42 eligible patients, tumor response and progression calculated by CA125 kinetics, with tumor response at 8 weeks and specific growth rate at progression, exhibited a significant correlation with progression-free and overall survival, similar to tumor response and progression by Gynecologic Cancer Inter Group criteria. CONCLUSIONS: The tumor response at 8 weeks higher than 1.77 appears to be a good surrogate of clinical response, whereas the definition of progression when CA125 increases above a value double than the nadir suggests a similar performance of growth rate at progression versus Gynecologic Cancer Inter Group criteria and warrants further investigation.

Docetaxel for metastatic breast cancer: two consecutive phase II trials.

BACKGROUND: Docetaxel is the most active agent for metastatic breast cancer, but the optimal treatment regimen as a single agent has yet to be defined. PATIENTS AND METHODS: Two consecutive monocentric phase II trials of docetaxel in metastatic breast cancer were carried out. In Trial I, 36 patients received docetaxel 35 mg/m2 weekly for 6 weeks every 8 weeks and in Trial II, 29 patients received docetaxel 100 mg/m2 day 1 every 21 days. RESULTS: Patient characteristics were comparable. However, patients with liver involvement comprised 25% of cases in Trial I and 55% in Trial II. The overall response rate on an intention-to-treat basis was 19% vs. 45% in Trial I and II respectively; time to progression was 3.8 vs. 7.5 months respectively, and overall median survival was comparable in each trial. CONCLUSION: Docetaxel given at 100 mg/m2 every three weeks appears to be a safe, effective regimen that can be applied in common clinical practice for the treatment of metastatic breast cancer.

Gemcitabine and vinorelbine as second-line treatment in patients with metastatic breast cancer: a phase II study.

BACKGROUND: To evaluate the feasibility and activity of gemcitabine and vinorelbine as a second/third-line approach in patients with advanced breast cancer. METHODS: Entered into the study were 51 consecutive patients. All had been previously treated with anthracyclines. Of these 51 patients, 36 had experienced failure or relapse after one chemotherapy line for advanced disease, and 15 after two chemotherapy lines. The dominant sites of involvement were brain in 4 patients (7.8%), liver in 22 (43.2%), lung in 10 (19.6%), bone in 10 (19.6), and soft-tissue in 5 (9.8%). Treatment consisted of vinorelbine 25 mg/m(2) and gemcitabine 1000 mg/m(2) administered on days 1 and 8 every 21 days. RESULTS: The scheme was well tolerated. Grade 3/4 neutropenia was observed in 11% of patients. Grade 3 nausea and vomiting occurred in 6%, and grade 2 neurotoxicity in 6%. No patients experienced grade 3/4 alopecia. The median relative dose intensity was 94.6% (49.7-100%) and 90.0% (23.1-100%) for vinorelbine and gemcitabine, respectively. Two patients (3.9%) were not evaluable for disease response, 4 (7.8%) attained a clinical complete response, 13 (25.5%) a partial response (for an overall response rate of 33.3%, 95% coefficient interval 20.0-46.0%), 23 (45.2%) showed stable disease, and 9 (17.6%) progressed. The median time to progression of responding patients was 10.8 months, and the median overall survival of the entire population was 17.8 months. CONCLUSIONS: Vinorelbine and gemcitabine is a manageable scheme with moderate activity in pretreated patients with advanced breast cancer.