Consolidation mFOLFOX6 Chemotherapy After Chemoradiotherapy Improves Survival in Patients With Locally Advanced Rectal Cancer: Final Results of a Multicenter Phase II Trial.

BACKGROUND: Adding modified FOLFOX6 (folinic acid, fluorouracil, and oxaliplatin) after chemoradiotherapy and lengthening the chemoradiotherapy-to-surgery interval is associated with an increase in the proportion of rectal cancer patients with a pathological complete response. OBJECTIVE: The purpose of this study was to analyze disease-free and overall survival. DESIGN: This was a nonrandomized phase II trial. SETTINGS: The study was conducted at multiple institutions. PATIENTS: Four sequential study groups with stage II or III rectal cancer were included. INTERVENTION: All of the patients received 50 Gy of radiation with concurrent continuous infusion of fluorouracil for 5 weeks. Patients in each group received 0, 2, 4, or 6 cycles of modified FOLFOX6 after chemoradiation and before total mesorectal excision. Patients were recommended to receive adjuvant chemotherapy after surgery to complete a total of 8 cycles of modified FOLFOX6. MAIN OUTCOME MEASURES: The trial was powered to detect differences in pathological complete response, which was reported previously. Disease-free and overall survival are the main outcomes for the current study. RESULTS: Of 259 patients, 211 had a complete follow-up. Median follow-up was 59 months (range, 9-125 mo). The mean number of total chemotherapy cycles differed among the 4 groups (p = 0.002), because one third of patients in the group assigned to no preoperative FOLFOX did not receive any adjuvant chemotherapy. Disease-free survival was significantly associated with study group, ypTNM stage, and pathological complete response (p = 0.004, <0.001, and 0.001). A secondary analysis including only patients who received ≥1 cycle of FOLFOX still showed differences in survival between study groups (p = 0.03). LIMITATIONS: The trial was not randomized and was not powered to show differences in survival. Survival data were not available for 19% of the patients. CONCLUSIONS: Adding modified FOLFOX6 after chemoradiotherapy and before total mesorectal excision increases compliance with systemic chemotherapy and disease-free survival in patients with locally advanced rectal cancer. Neoadjuvant consolidation chemotherapy may have benefits beyond increasing pathological complete response rates. See Video Abstract at http://links.lww.com/DCR/A739.

Availability, Use, and Barriers to Cardiac Rehabilitation in LMIC.

BACKGROUND: Cardiac rehabilitation (CR) is a cornerstone of secondary prevention of ischemic heart disease. It is critically important in low- and middle-income countries (LMIC), where the burden of ischemic heart disease is substantial and growing. However, the availability and utilization of CR in LMIC is not systematically known. OBJECTIVES: This study sought to characterize the availability, use, and barriers to the use of CR. METHODS: Electronic databases (Cochrane Library, EMBASE, PubMed, Web of Science) were searched from January 1, 1980 to May 31, 2013 for articles on CR in LMIC. Citations on availability, use, and/or barriers to CR were screened for inclusion by title, abstract, and full text. Data were summarized by region or country to determine the characteristics of CR in LMIC and gaps in the peer-reviewed biomedical publications. RESULTS: Our search yielded a total of 5,805 citations, of which 34 satisfied full inclusion and exclusion criteria. The total number of CR programs available ranged from 1 in Algeria and Paraguay to 51 in Serbia. Referral rates for CR ranged from 5.0% in Mexico to 90.3% in Lithuania. Attendance rates ranged from 31.7% in Bulgaria to 95.6% in Lithuania, and CR attendance was correlated with higher educational background. The most commonly cited barrier to CR in LMIC was lack of physician referral. CONCLUSIONS: Our results illustrate that the published reports reflects heterogeneity of CR availability and use in LMIC. Overall, CR is insufficiently available and underutilized. Further characterization of CR in LMIC, especially in Asia and Africa, is necessary to develop targeted strategies to improve availability and utilization. Patient, physician, and systems factors must be addressed to overcome barriers to participation in CR in LMIC.