BACKGROUNDOur original paper, published in 1992, reported a median overall survival after first relapse in breast cancer of 26 months. The current retrospective review concentrates more specifically on patients with first systemic relapse, recognizing that subsets of patients with local recurrence are potentially curable.METHODSRecords of 5,168 patients from a largely breast-cancer-specific oncology practice were reviewed to identify breast cancer patients with their first relapse between 1996 and 2006 after primary treatment. There were 189 patients diagnosed with metastatic disease within 2 months of being seen by our therapeutic team and 101 patients diagnosed with metastatic disease greater than 2 months. The patients were divided in order to account for lead-time bias than could potentially confound the analysis of the latter 101 patients.RESULTSMedian survival for our primary study population of 189 patients was 33 months. As expected, the median survival from first systemic relapse (MSFSR) for the 101 patients excluded because of the potential for lead-time bias was better at 46 months. Factors influencing prognosis included estrogen receptor (ER) status, disease-free interval (DFI), and dominant site of metastasis. Compared with our original series, even with elimination of local-regional recurrences in our present series, the median survival from first relapse has improved by 7 months over the past two decades.CONCLUSIONThe new benchmark for MSFSR approaches 3 years.
To determine if a low fixed dosing strategy of capecitabine would produce comparable clinical activity with less adverse toxicities compared to published data with higher doses in the setting of metastatic breast cancer (mBC). We retrospectively analyzed patients treated with a low fixed dose of capecitabine (CAPE-L) at 1,000 mg twice daily for 14 days every 21 days. Outcomes included clinical benefit rate (CBR), overall response rates (ORR), time to progression (TTP), and overall survival (OS). A historical comparison group of mBC patients treated on 12 prior trials at the package-insert dose of capecitabine (n = 1,949) was utilized. Eighty-six patients were analyzed in our cohort. Positive hormone receptor status (79.1 vs. 50.6 %), and capecitabine as first-line chemotherapy (44.2 vs. 16.5 %) were more frequent in our cohort relative to the historical comparison. The median starting dose in our cohort was 633.5 mg/m(2). The CBR was similar between the CAPE-L and the standard dose cohorts (55.8 vs. 49.5 %), as was ORR (24.3 vs. 24 %), and median TTP (7 mo, 95 % CI 5.5-8.5 vs. 5.1 mo, 95 % CI 4.5-5.7). Median OS was longer in our cohort (24 mo, 95 % CI 16.8-31.2) than the historic standard dose cohort (12.1 mo, 95 % CI 9.6-14.4), a difference that was likely explained by the higher proportion of patients in the CAPE-L cohort who received capecitabine as first-line chemotherapy and who had hormone receptor positive disease. As expected, adverse events were less frequent with CAPE-L. We found that CAPE-L, which translates into a dose of 600-650 mg/m(2), appeared to have good clinical efficacy and acceptable toxicity.
Background Hispanics often have disparities at the end of life. They are more likely to die full code and less likely to have discussions regarding prognosis and do not resuscitate (DNR)/do not intubate (DNI), despite studies showing Hispanic values comfort over the extension of life. Barriers to patient-centered care include language,socioeconomic status and health literacy. Context We evaluated the impact of palliative care (PC) consults on the change of code status and hospice referrals, comparing seriously ill Hispanic and non-Hispanic white patients. Method A retrospective cohort study of all white and Hispanic patients referred to the PC service of a county hospital from 2006 to 2012. We evaluated ethnicity, language, code status at admission and after PC consult, and hospice discharge. Chi-squared tests were used to analyze characteristics among three groups: non-Hispanic white, English-speaking Hispanic, and Spanish-speaking Hispanic patients. Results Of 925 patients, 511 (55%) were non-Hispanic white, 208 (23%) were English-speaking Hispanic, and 206 (22%) were Spanish-speaking Hispanic patients. On admission, there was no statistically significant difference in code status among the three groups (57%, 64%, and 59% were full code, respectively, p = 0.5). After PC consults, Spanish-speaking Hispanic patients were more likely to change their code status to DNR/DNI when compared with non-Hispanic white and English-speaking Hispanic patients (44% vs. 32% vs. 28%, p = 0.05). Spanish-speaking Hispanic patients were more likely to be discharged to hospice when compared with English-speaking Hispanics and non-Hispanic whites (33%, 29%, and 23%, respectively, p = 0.04). Significance of results Spanish-speaking Hispanic patients were more likely to change from full code to DNR/DNI compared with non-Hispanic white and English-speaking Hispanic patients, despite similar code status preferences on admission. They were also more likely to be discharged to hospice. PC consults may play an important role in helping patients to align their care with their values and may prevent unwanted aggressive interventions at the end of life.
Background: Capecitabine (CAPE) has clinical activity in metastatic breast cancer (MBC) at an FDA approved dose of 1,250mg/m2 twice daily for 14 days every 21 days (BID Q14). This schedule has been adopted by many United States oncologists, although the starting dose is often reduced. To determine if lower doses of CAPE have comparable clinical activity as the FDA approved dose, we performed a retrospective analysis. Methods: A retrospective review of records from a large breast cancer oncology practice and from Sylvester Cancer Center Deerfield Beach from 2000–2008 was performed after approval of the University of Miami IRB. Standard practice was CAPE low dose (CAPE-L) 1,000mg BID Q14. Primary outcome was clinical benefit rate (CBR) defined as complete response (CR), partial response (PR) or stable disease (SD) lasting for ≥ 6 months. Response rates (RR) in patients with measurable disease, progression free survival (PFS), overall survival (OS) defined as time period between beginning of CAPE and death, and adverse events (AE) defined according to the NCI CTCAE version 3.0 were secondary endpoints. A literature review was performed for comparison. Results: Data from 296 patients (pts) with HER-2 negative MBC were reviewed. Of those, 73 received CAPE-L at a starting dose between 303 mg/m2 and 965 mg/m2 (median 614 mg/m2) BID Q14. Median number of prior lines of therapy was 1 (range 0–10); 34/73 (46.6%) of pts received CAPE-L as first line therapy. 23.3% of pts required dose reductions because of palmar-plantar erythrodysesthesia (PPE) (44%), diarrhea (17%), mucositis (11%) or other (28%). RR in 61 patients with measurable disease was 25%. PR occurred in 16/73 (22%), CR (0%), SD ≥ 6 months 21/73 (29%), and PD 31/73 (43%), with a CBR of 37/73 (51%). Median PFS and OS were 6.2 months (95% CI, 4.4 to 8) and 21.4 months (95% CI, 14.4 to 28.6), respectively. AEs are reported in table 2. We recognized 12 trials that used the FDA approved dose in 1,949 patients. Bidimensionally measurable disease was present in 1,630 patients. CBR was reported as 62% in 1,006 patients and RR as 24% in 398. Weighted averages of median PFS and OS were 5.1 months (95% CI, 4.5 to 5.7) and 12 months (95% CI, 9.6 to 14.4), respectively. Detailed toxicity data were available in 11 trials with 1,883 patients. A comparison of current series with literature review at standard dose follows (table 1). Conclusion: Compared with previously published data, CAPE-L appeared more tolerable with comparable clinical efficacy as package insert doses. Citation Information: Cancer Res 2012;72(24 Suppl):Abstract nr P1-12-03.
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