Esophageal cancer: Outcome and potential benefit of esophagectomy in elderly patients.

BACKGROUND: This analysis evaluated the morbimortality and the potential benefit of esophagectomy for cancer in elderly patients. METHODS: Patients who underwent esophagectomy for EC were divided into elderly (≥70 years) and nonelderly (<70 years) groups. The groups were compared regarding patient and tumor characteristics, postoperative morbimortality, and disease-free, overall and cancer-specific survival. RESULTS: Sixty-one patients were classified into elderly, and 187 into nonelderly groups. The elderly were characterized by a higher rate of WHO score (p < 0.0001), higher cardiac (p < 0.004) and renal (p < 0.023) comorbidities. The rate of neoadjuvant therapy and especially of neoadjuvant CRT was significantly lower in elderly patients (p < 0.018 and p < 0.007). Operative morbidity was also higher in this group (p < 0.024). The 30- and 90-day mortality was 8.2 and 11.5%, respectively in elderly patients and 0.5 and 3.2% in nonelderly patients (p < 0.004 and p < 0.012). This 90-day mortality decreased when specific surgery-related deaths were taken into consideration. OS and DFS were significantly better in the nonelderly group (p < 0.003 and p < 0.005) while no difference was observed for cancer-specific survival (CSS). CONCLUSION: No difference in CSS was observed. Although elderly patients with EC had higher postoperative morbimortality, the age should not be a criterion whether to perform, or not to perform, esophagectomy. This decision must be based on the balance between the patient's general condition and aggressive disease.

Adjuvant gemcitabine and concurrent continuous radiation (45 Gy) for resected pancreatic head carcinoma: a multicenter Belgian Phase II study.

PURPOSE: To evaluate the feasibility and tolerance of a postoperative course of gemcitabine (GEM) combined with continuous radiation after curative resection of pancreatic adenocarcinoma. METHODS AND MATERIALS: Thirty patients (median age, 61 years; performance status, 0 to 1) with Stage II and III curatively resected pancreatic head adenocarcinoma were included. Gemcitabine 1000 mg/m2 (3 out of 4 weeks, two cycles) was given within 8 weeks of surgery and followed by GEM 300 mg/m2 weekly combined with continuous radiation (45 Gy in 25 fractions, 1.8 Gy per fraction). RESULTS: For GEM alone, all patients received the two courses with dose reductions in 14 of 30 patients (46%). All but 3 patients completed full chemoradiation; 1 stopped radiation because of subocclusion of a gastroenterostomy, and 2 did not start owing to disease progression. Reduction in GEM during radiation was necessary in 12 of 30 patients (40%). No toxic death was noted; World Health Organization Grade 3/4 hematologic and nonhematologic toxicities were seen in 10 of 30 patients (33%) and 3 of 30 patients (10%), respectively. After a median follow-up of 19 months, no late toxicity was reported. Eleven patients died from progressive disease; median disease-free survival and overall survival were 14.5 and 19 months, respectively. CONCLUSION: This adjuvant combination is well tolerated and can be safely administered after curative surgery for pancreatic cancer. Further evaluation of this regimen is ongoing.

Postoperative adjuvant gemcitabine and concurrent radiation after curative resection of pancreatic head carcinoma: a phase II study.

PURPOSE: The addition of radiation to adjuvant 5-fluorouracil for the treatment of pancreatic cancer has not yet shown any definite benefit. Gemcitabine (GEM) has potential activity in advanced pancreatic cancer and is a powerful radiosensitizer. We evaluated the feasibility of postoperative administration of GEM alone, followed by concurrent GEM and irradiation (RT) after curative resection for pancreatic adenocarcinoma. METHODS AND MATERIALS: GEM 1000 mg/m(2) on Days 1 and 8 every 21 days for three courses was given within 8 weeks after surgery and was followed by GEM 300 mg/m(2) weekly +40 Gy in a split course. Twenty-two patients (median age 59 years, range 39-74, Performance Status 0-1) with Stage II and III curatively resected pancreatic head adenocarcinoma were included. RESULTS: For GEM alone, all patients received the three planned courses, with dose reductions in 7 (32%) of 22 patients. All patients, except two, completed full chemoradiation; one received only 20 Gy because of both World Health Organization Grade 4 vomiting and thrombopenia and the other stopped RT after 32 Gy because of early disease progression. No reduction in GEM during RT was necessary; no toxic death was noted; and World Health Organization Grade 3-4 hematologic and nonhematologic toxicities occurred in 8 (36%) and 7 (nausea, vomiting) (32%) of 22 patients respectively. No late toxicity developed. After a median follow-up of 15 months, 11 patients were alive, and 2 patients had died of causes unrelated to their disease or toxicity, The median disease-free survival and overall survival was 6 and 15 months, respectively. CONCLUSION: This adjuvant regimen was well tolerated and can be easily administered after curative surgery for pancreatic cancer. Its intensification with continuous RT is currently being investigated.

Tolerance and efficacy of gemcitabine and gemcitabine-based regimens in elderly patients with advanced pancreatic cancer.

OBJECTIVES: Gemcitabine is the backbone therapy of patients with advanced pancreatic cancer. Its tolerability and efficacy remain poorly studied in elderly. METHODS: We selected patients coming from phase 2 and 3 studies, conducted between January 2001 and December 2004 in our department, evaluating gemcitabine-based first-line chemotherapy. We evaluated the treatment efficacy, tolerability, and compared patients younger than 70 years (group A) and aged 70 years and older (group B). We assessed the contribution of patient-, tumor- and treatment-related variables on the prognostic of patients aged 70 years and older. RESULTS: Ninety-nine patients were studied: groups A (n = 57) and B (n = 42) treated by gemcitabine alone (n = 61) and gemcitabine-based combination (n = 38). Tumor growth control (66.6% vs 59.6%), time to progression (119 vs 104 days), and overall survival (240 vs 220 days) were comparable for groups A and B, respectively. For patients (n = 47) receiving a second-line chemotherapy (group A, n = 33; group B, n = 14), the efficacy and toxicity were similar in both group. Baseline alanine aminotransferase and Karnofski performance status were independent negative prognostic factors for elderly patients. CONCLUSIONS: Our study suggests that elderly patients undergoing gemcitabine do as well than younger patients.

Squamous cell carcinoma of the esophagus: multimodal therapy in locally advanced disease.

The aim of this prospective study is to report our experience in the multimodal management of locally advanced esophageal squamous cell carcinoma (LAESC; stage III cTNM), focusing on the results of chemoradiotherapy followed by surgery. These findings were compared to the results of a standard group of patients with locally advanced esophageal carcinoma (LAEC; stage III pTNM) treated in our center with surgery alone. Sixty-one patients with LAESC underwent preoperative chemoradiotherapy (5-fluorouracil + cisplatin) with concomitant 45 Gray radiotherapy in a 5-week course. Transthoracic esophagectomy was performed 4 to 5 weeks after the end of the neoadjuvant therapy. Thirty-eight patients underwent surgery, and 37 of them had resections (resectability: 97% in the multimodal group; 84% in the standard surgical series; p = 0.07). The R0 (complete) resection rate was 78% compared to 56% in the standard surgical group (p <0.03). Eleven patients had no residual tumor in the resected specimen (pathologic complete response: pCR: 30%). The operative mortality rate was 19% compared with 8.8% in the standard series. The overall median survival of the resected patients was 21 months, with a 5-year survival rate of 11% (14% in the surgical group; NS). The 3-year and 5-year survival rates were 34% for the pCR group and respectively 5% and 0% for the group with pathologic incomplete response (pIR; p <0.05). The median survival was 28 months for the pCR patients and 19 months for the pIR group. In this non-randomized trial, preoperative chemoradiotherapy in LAESC seems to increase the resectability and R0 resection rates, to allow a higher pCR rate and a longer survival only in the pCR group, at the expense of an inadequate increase in operative mortality. This multimodal treatment cannot be proposed as a standard procedure unless less toxic regimens are developed, increasing the benefits with better local and distant failure control and decreasing operative mortality.