Abstract:ObjectiveThis phase i study aimed to determine the maximal tolerated dose of cisplatin administered every 2 weeks with infusional 5-fluorouracil (5fu) and concurrent radiation therapy (rt) in patients after complete resection of gastric adenocarcinoma.
MethodsPatients with resected stage ib to iv (M0) gastric adenocarcinoma were treated with 12 weeks of infusional 5fu (200 mg/m 2 daily) and with rt (45 Gy in 25 fractions starting on day 16). Cisplatin was administered in escalating doses (0,20, 30, and 40 mg/m… Show more
“…The exclusion criteria ruled out patients declining adjuvant chemoradiation or not fit for it, those found to have distant disease at the time of the operative procedure, patients with pathology other than adenocarcinoma, and those with T1N0 or T2aN0 disease. The patients received adjuvant 5-fluorouracil (FU)-based chemotherapy combined with radiotherapy (45/Gy), either according to the MacDonald protocol or as part of an institutional phase 1 study combined with radiotherapy (45 Gy/25 fractions) delivered using three-dimensional conformal or intensity-modulated radiation therapy (IMRT) techniques [17][18][19].…”
The study findings suggest that laparoscopic gastrectomy is an oncologically safe procedure for advanced gastric cancer with outcomes similar to those for open resection.
“…The exclusion criteria ruled out patients declining adjuvant chemoradiation or not fit for it, those found to have distant disease at the time of the operative procedure, patients with pathology other than adenocarcinoma, and those with T1N0 or T2aN0 disease. The patients received adjuvant 5-fluorouracil (FU)-based chemotherapy combined with radiotherapy (45/Gy), either according to the MacDonald protocol or as part of an institutional phase 1 study combined with radiotherapy (45 Gy/25 fractions) delivered using three-dimensional conformal or intensity-modulated radiation therapy (IMRT) techniques [17][18][19].…”
The study findings suggest that laparoscopic gastrectomy is an oncologically safe procedure for advanced gastric cancer with outcomes similar to those for open resection.
“…Three patients without doselimiting toxicity (dlt) were treated per cohort, in a standard 3+3 dose-escalation design: If 1 of 3 patients experienced a dlt, 3 further patients were treated at the same dose level. Cisplatin every 2 weeks was added to the treatment plan in escalating dose intensity 5 . In cohorts 1-4, the cisplatin dose was 0 mg/m 2 , 20 mg/m 2 , 30 mg/m 2 , and 40 mg/m 2 respectively, given 4 times starting at week 1 (that is, weeks 1, 3, 5, and 7).…”
Section: Chemotherapymentioning
confidence: 99%
“…Toxicities experienced by the patients included skin toxicity (rashes, dryness, erythema), weight loss, fatigue, anorexia, nausea, dehydration, gastritis, hand-foot syndrome, sepsis, hyponatremia, and hematologic events 5 Figure 1 shows the mean scores for global qol and for the functional and symptom scales at each time point. Table iii shows median differences from baseline in the scores for each domain at completion of radiation and at 4 weeks, 6-12 months, and 2-3 years after crt completion.…”
Section: Toxicitymentioning
confidence: 99%
“…Here, we present a prospective evaluation of qol for patients with completely resected gastric or gastroesophageal adenocarcinoma undergoing adjuvant abdominal radiation therapy with chemotherapy using infusional 5-fluorouracil (5fu) and escalating doses of cisplatin in a single-institution phase i study. Based on the results of that study, a phase ii study is currently underway 5 .…”
ObjectiveOur phase i study prospectively evaluated quality of life (qol) in patients undergoing adjuvant chemoradiation for gastric adenocarcinoma.
MethodsThirty-three patients receiving radiotherapy (45 Gy in 25 fractions), together with 12 weeks of infusional 5-fluorouacil and escalating doses of cisplatin every 2 weeks, completed the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 at five time points: baseline, completion of radiation, 4 weeks after completion of radiation, 6-12 months after completion of chemoradiation, and 2-3 years after completion of chemoradiation.
ResultsMean age of the patients was 56 years (range: 31-77 years); 55% of the patients were male. Median followup was 2.7 years (range: 0.3-5 years). The 3-year overall survival was 83%. Five patients experienced dose-limiting toxicity (dlt). Median scores on global qol and on the social, role, emotional, nausea and vomiting, and fatigue scales showed clinically and statistically significant worsening at completion of radiation. Statistical but not clinical worsening was found for the physical and appetite scales. By 6-12 months, no subscale showed a difference, on average, from the baseline score. However, up to 45% of the patients remained below baseline on at least 1 subscale. Patients with dlt had worse scores on the emotional and the nausea and vomiting scales. Scores for global qol and for nausea and vomiting were significantly associated with chemotherapy dose.
ConclusionsDuring chemoradiation, qol is impaired. Although most scores return to baseline, recovery may take 6-12 months, and subscale scores remain below baseline in a significant proportion of patients.
“…Two-sided P values of less than 0.05 were used to assess statistical significance. MacLellan et al [12,13] have reported on recurrence outcomes. Of the 197 patients treated, 71 recurrences (36 %) were identified, of which 57 (80 %) were classified as having distant metastases as either the only site of failure Retrospective assessment of patterns of recurrence relative to radiotherapy volumes for… 889 or as a component of failure.…”
Background Since the Intergroup 0116 study was published in 2000, adjuvant postoperative chemoradiotherapy using CT-planned and 3D conformal/intensity-modulated radiotherapy has been offered routinely to fit patients with resected gastric cancer at Princess Margaret Hospital .The objective of this study was to analyze patterns of disease recurrence with respect to the radiotherapy volumes. Methods For the date and site (local, locoregional, or distant) of the first recurrence, medical records were reviewed for all patients treated at Princess Margaret Hospital with adjuvant chemoradiotherapy for resected gastric adenocarcinoma (January 1, 2000 to November 30, 2009). Patients whose recurrences were limited to local and/or regional sites were selected for further analysis. Available diagnostic imaging of the recurrence site was registered to the original planning radiotherapy dataset for contouring. If necessary to respect changes in anatomy, the contour was translocated on the basis of anatomic descriptors. The center of mass for each recurrence was identified as a point and its location was categorized according to the isodose encompassing it; in field (90 % or more), marginal (50-89 %), or out of field (less than 50 %). Results Of all 197 patients, 14 (7 %) had isolated locoregional failure, constituting 20 % of all 71 patients with a recurrence. Successful fusions were feasible in five cases. Of these recurrences, four were in field and one was marginal. In a further four cases, visual inspection was used, showing one in-field recurrence, one marginal recurrence, and two out-of-field recurrences. In five patients, either a useable original dataset or diagnostic imaging of the recurrence was not available. Conclusions The rates of isolated local/locoregional tumor recurrence in this study were low. Of the small number of recurrences available for analysis, most (five of nine) were in field. Further studies involving a larger cohort of patients might allow a more meaningful analysis of trends in the recurrence site with evolving radiotherapy techniques.
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