Effect of a Structured Teaching Module Including Intensive Prophylactic Measures on Reducing the Incidence of Capecitabine-Induced Hand-Foot Syndrome: Results of a Prospective Randomized Phase III Study.

LESSONS LEARNED: A structured teaching module including intensive prophylactic measures to alleviate hand-foot syndrome (HFS) during capecitabine therapy is feasible but ineffective at protecting patients from HFS. Pharmacologic therapeutic interventions should be investigated for the management of this complication. BACKGROUND: Capecitabine-induced hand-foot syndrome (HFS) has a detrimental effect on quality of life. The effect of a structured teaching module including intensive prophylactic measures was evaluated. METHODS: This non-crossover phase III double-blinded clinical trial randomized patients in a 1:1 ratio to either a control group or to a group administered a structured teaching model including intensive prophylactic measures on HFS administered by a trained oncology nurse at regular intervals (case) versus standard information on HFS care administered by treating clinician (control). The primary endpoint was comparison of fraction of patients in both arms developing at least grade 2 HFS. RESULTS: Between June 15, 2016, and April 4, 2018, 280 patients (140 to case and 140 to control) were enrolled. The median number of capecitabine chemotherapy cycles was eight; 269 patients (96%) were evaluable for HFS, of whom 89 patients (33.08%) developed at least grade 2 HFS (grade 2 HFS, 73 patients [26.1%]; grade 3 HFS, 16 patients (5.7%}). There was no difference in at least grade 2 HFS between evaluable case and control arms of the study (control group, 45/135 [33.3%]; case, 44/134 [32.8%]; p = .93). CONCLUSION: The use of a structured teaching module including intensive prophylactic measures was feasible, but this did not reduce the incidence and severity of capecitabine-induced HFS.

Clinico-pathological correlates and survival outcomes in 214 resected ampullary adenocarcinomas - are outcomes different in intestinal and pancreatobiliary subtypes with adjuvant gemcitabine?

BACKGROUND: Evidence suggests that intestinal type (IT) and pancreatobiliary (PB) subtypes of ampullary adenocarcinoma (AC) may have different outcomes. The current study evaluated differences in outcomes between these subtypes and the benefit of adjuvant chemotherapy (AT). METHODS: A prospectively maintained database of patients who underwent upfront resection for AC from January 2012 to March 2016 was conducted. A dedicated pathologist reported differentiation between IT and PB subtypes. RESULTS: 214 patients were included for analysis: 105 PB subtype and 109 IT subtype. With a median follow up of 46.3 months, estimated 4 year overall survival (OS) was 65.8%. In patients with stage II-III disease, lymph-node ratio (LNR) < 0.2 [Not reached (NR) vs. 30.72 months; p = 0.002], absence of perineural invasion (PNI) (NR vs. 31.61 months; p = 0.032) and AT (gemcitabine - 96.1%) (NR vs. 22.28 months) were prognostic for superior OS. There was no difference in OS between IT and PB subtypes, but both subtypes with stage II-III disease benefitted from AT statistically as compared to observation (IT: NR vs. 28.62 months; PB: 18.46 months vs. 58.09 months; p < 0.001). CONCLUSIONS: AC-IT and AC-PB did not have a different OS when treated with resection and adjuvant gemcitabine, though adjuvant therapy benefitted both subtypes individually.

An evaluation of early-onset fatigue and the related coping strategies in patients with gastrointestinal cancer: A prospective pilot study.

BACKGROUND: Cancer related fatigue (CRF) has been studied extensively and it has the worse impact as compared to pain on quality of life (QOL) of cancer patients. MATERIAL AND METHODS: Prospective study was conducted at Tata Memorial center in Gastrointestinal (GI) cancer patients to assess fatigue with FACIT and PIPER scales. This was also to assess qualitative data on coping strategies in these patients. RESULTS: Severe to moderate fatigue was commonly associated with sedentary to moderate activities (P = 0.049) whereas it was less common as education level increases (P = 0.031). Baseline pain was significantly associated with increase in fatigue (P = 0.033). This study also suggests that fatigue increases with as number of chemotherapy cycles increase. Qualitative data analysis revealed that majority of the patients used resting and energy conservation in the form of sitting, lying down. Most of them were following high protein diet (with or without supplementary protein powder) and little exercise such as walking. CONCLUSION: Patients with GI cancer receiving chemotherapy were found to have fatigue, which increased during the subsequent cycles. Patients with sedentary lifestyle and experiencing pain at baseline were found to have more fatigue. Coping strategies adopted by majority of patients were resting and a high-protein diet.