Cost-effectiveness of low-dose continuous infusion gemcitabine plus cisplatin versus standard dose gemcitabine plus cisplatin in stage III and IV non-small cell lung cancer

The purpose of this study was to assess the efficacy of low-dose continuous infusion gemcitabine 200 mg/m[2] once weekly on three consecutive out of 4 weeks for 6 cycles compared to the standard-dose gemcitabine 1000 mg/m[2] plus cisplatin in stage III and IV non-small cell lung cancer. Experimental Forty patients of non-small cell lung cancer with stage III and IV who are indicated for chemotherapy received low-dose continuous infusion gemcitabine 200 mg/m[2] plus cisplatin compared to forty patients of non-small cell lung cancer with stage III and IV who received the standard dose gemcitabine 1000 mg/m[2] plus cisplatin. The maximum duration of infusion of gemcitabine in combination with cisplatin was 24 hours with a dose of 200 mg / m[2] / day once weekly on three consecutive out of 4 weeks for 6 cycles. Cisplatin was given once every cycle with a dose of 100 mg/m[2]. This was compared to the standard-dose of gemcitabine 1000 mg/m[2] combined with cisplatin 100 mg/m[2] every 3 weeks for 6 weeks. Severe stomatitis, oesophagitis and myelosuppression were the worst common dose-limiting toxicities. Febrile neutropenia was observed in 8 out of the 40 patients who had received low-dose continuous infusion of gemcitabine as they developed bacteraemia. Occasional nausea, vomiting and diarrhea were also reported in both arms. There were 6 complete responses and 4 partial responses in the arm who received low-dose continuous infusion compared to 8 patients who had complete response and 4 patients with partial response in the standard dose arm. Low-dose continuous infusion gemcitabine for 24 hours with a dose of 200 mg/m[2]/day once weekly on three consecutive out of 4 weeks for 6 cycles gives results that are comparable to those of the standard-dose of gemcitabine but with a higher toxicity profile

Pre-operative chemo-radiotherapy followed by surgery compared to surgery alone in patients with stage II and III esophageal cancer

Current primary treatment options for esophageal cancer are surgery only or concomitant chemo-radiotherapy [CRT] and the long-term survival of patients with locally-advanced disease is rare. Pre-operative concomitant CRT seems to be beneficial, mostly in patients who achieve a complete pathologic response [pCR] after CRT. In this study the efficiency and toxicity of pre-operative CRT in patients with locally-advanced esophageal cancer was analyzed as well as the influence of CRT on the survival. Thirty patients with stages II and III esophageal cancer were randomly assigned to surgery alone and another 30 patients were assigned to surgery after 80 mg/m[2] cisplatin on day 1, 800 mg/m[2] fluorouracil on days 1 - 4, with concurrent radiotherapy of 45 Gy given in 22 fractions over 4.5 weeks. The primary end-point was progression-free survival and the secondary end-points were overall survival, tumor response, toxic effects, patterns of failure and quality of life. Progression-free survival and overall survival did not differ between both groups [PFT P=0.16, Median survival P=0.34]. The chemo-radiotherapy and surgery group had more complete resections with clear margins than did the surgery alone group [24 of 30 [80%] versus 14 of 30 [47%], P= 0.001], and had fewer positive lymph nodes [11 of 30 [37%] versus 20 of 30 [67%], P= 0.012]. Neo-adjuvant chemo-radiation [NCRT] followed by surgery is associated with a small non-statistically significant improvement in the overall survival. Whether this benefit is sufficient to warrant the considerable expense and risk associated with NCRT should be the subject of further larger randomized trials