Symptom improvement as prognostic factor for survival in cancer patients undergoing palliative care: a pilot study.

BACKGROUND: The Edmonton Symptom Assessment Scale (ESAS) is a validated tool for physical symptom assessment in palliative care practice which evaluates symptoms through a numeric scale from 0 to 10. The use of symptom improvement as a prognostic factor is controversial. To this purpose, a pilot study in advanced cancer patients now undergoing only palliative care was conducted. METHODS: Patients were considered eligible if no longer able to receive any anticancer treatment; they were scheduled to undergo ESAS assessment at the hospitalization and hospital discharge time points. Symptoms' scores were divided into three severity classes: mild, moderate and severe. Differences across symptoms' classes between hospitalization and hospital discharge time points were analysed with the paired-data McNemar test, according to tumour types. RESULTS: ESAS assessment was administered to 68 patients with gastrointestinal (39 patients) and non-small cell lung cancer (29 patients); median age was 69 years; Karnofsky Performance Status was 50 in 27 (39.7%) patients and >50 in 41 (60.3%) patients. Palliative Prognostic Score was A for 26 (38.2%) patients, B for 37 (54.4%) patients and C for 5 (7.4%) patients. A statistically significant reduction of severe severity class rates was observed. Symptom improvement correlates with survival improvement: Palliative Prognostic Score (hazard ratio (HR) 2.95, 95% CI 1.35-6.41, p = 0.006) and anorexia (HR 3.21, 95% 1.33-7.72, p = 0.009) appear to be prognostic factors for survival at the multivariate analysis for gastrointestinal cancer patients; asthenia is the only significant variable (HR 5.11, 95% CI 1.86-14.03, p = 0.002) for non-small cell lung cancer patients. CONCLUSIONS: Symptom improvement according to ESAS after palliative care treatment represents an important prognostic for survival in patients no longer suitable to receive any anticancer active therapies.

A phase II study of biweekly paclitaxel (P) and gemcitabine (G), followed by maintenance weekly paclitaxel in elderly patients with advanced non-small cell lung cancer (NSCLC).

BACKGROUND: This phase II study was conducted to evaluate the efficacy and safety of a novel combination of paclitaxel (P) and gemcitabine (G) in an every 2 weeks schedule followed by weekly paclitaxel (P) as first-line treatment in elderly patients with locally advanced or metastatic NSCLC. METHODS: Elderly patients (> or =65 years of age) with 1997 TNM stage IIIB (pleural effusion)/stage IV NSCLC, performance status (PS) of 0-2 and normal organ function were eligible. Therapy consisted of P at 150 mg/m(2) and G at 2000 mg/m(2) administered every 2 weeks for 3 cycles followed, in progression-free patients, by P at 80 mg/m(2) every week for 6 consecutive weeks every 8 weeks for 2 cycles. RESULTS: Fifty-three eligible patients were enrolled: M/F 51/2; stage IIIB/IV 8/45; PS 0, 40%, PS 1 51%, PS 2 9%; median age, 73 years (range 67-82). The overall response rate was 32% (95% confidence interval [CI]: 19-45). The median overall survival was 7 months (95% CI: 5-9); the median progression-free survival was 5 months (95% CI: 3-6); and the 1- and 2-year survivals were 28.3% and 10.1%, respectively. Both phases of the treatment protocol were well tolerated. CONCLUSIONS: Biweekly P/G followed by weekly P is well tolerated and active as first-line therapy for elderly NSCLC patients.

Bi-weekly chemotherapy with cisplatin, epirubicin, folinic acid and 5-fluororacil continuous infusion plus g-csf in advanced gastric cancer: a multicentric phase II study.

BACKGROUND: It has been demonstrated that the 3-weekly PELF regimen is superior to FAM and FAMTX in advanced gastric cancer. The aim of this multicentric phase II study was to evaluate the efficacy and tolerability of a PELF regimen, given every 2 weeks as a first-line therapy in patients with unresectable or metastatic gastric carcinoma. METHODS: Fifty-nine patients were treated with the following schedule: cisplatin (40 mg/m2, day 1), epirubicin (30 mg/m2, day 1), 5-fluorouracil (400 mg/m2 bolus, followed by 600 mg/m2, 22 h continuous infusion, day 1 and 2) and folinic acid (100 mg/m2, 2-h infusion, day 1 and 2). G-CSF (5 microg/kg) was administered on day 6, 8, 10, and 12. Cycles were repeated every 2 weeks for a maximum of twelve courses. RESULTS: Of the 52 evaluable patients, three (5.8%) complete responses, and 15 (28.8%) partial responses were observed, for an overall response rate of 34.6%. The median duration of response was 8 months. Nineteen patients had stable disease and 15 progressed on therapy. At a median follow-up of 12 months, the median time to progression was 8 months and the median survival duration was 13 months, with a 1-year survival rate of 53.5%. Grade 3 or 4 observed toxicities were: neutropenia in 26 patients (44%), thrombocytopenia in four patients (6.7%), and mucositis in seven patients (11.9%). CONCLUSIONS: The bi-weekly PELF regimen seems to be feasible with an acceptable toxicity profile and an activity comparable to the 3-weekly schedule.