Investigation of a Patient Reported Outcome tool to assess radiotherapy-related toxicity prospectively in patients with lung cancer.

BACKGROUND AND PURPOSE: There is a paucity of data regarding the feasibility and relevance of Patient Reported Outcome (PRO) tools to assess radiotherapy-related toxicity in lung cancer. MATERIAL AND METHODS: From January to June 2013, lung cancer patients undergoing thoracic radiotherapy/chemo-radiotherapy completed nine patient-adapted Common Terminology Criteria for Adverse Events (CTCAE), the European Organisation for Research and Treatment of Cancer Quality of Life (QoL) questionnaire and the Hospital Anxiety and Depression Scale (HADS) at baseline, the end of radiotherapy and at follow-up. Clinicians completed the same CTCAE items and agreement between patients' and clinicians' reporting was assessed using weighted kappa coefficients. QoL and HADS scores were correlated with the patients' and clinicians' reported toxicity. RESULTS: 70/116 patients completed the questionnaires for at least one time point excluding baseline. Agreement between patients' and clinicians' reported toxicity ranged from slight to substantial. Most discrepancies were within one grade and patients reported greater severity than clinicians for most symptoms. QoL and HADS scores were more strongly correlated with the patients' compared to clinicians' matching toxicity reports. The PRO tool was found to be statistically reliable. CONCLUSIONS: The use of a PRO tool in lung cancer radiotherapy is feasible, reliable and acceptable to patients. PROs should be integrated in future clinical trials evaluating new radiotherapy approaches to assess toxicity.

Randomised phase II trial of 4 dose levels of single agent docetaxel in performance status (PS) 2 patients with advanced non-small cell lung cancer (NSCLC): DOC PS2 trial. Manchester lung cancer group.

BACKGROUND: The role of chemotherapy for advanced NSCLC patients and ECOG PS2 remains controversial. We evaluated 4 doses of 3-weekly docetaxel to identify a less toxic, clinically effective dose. METHODS: Seventy-three patients with stage III (22%) (unsuitable for radical surgery/radiotherapy) and IV (78%) NSCLC were randomized to receive 4 doses of 3-weekly docetaxel, for 4 cycles: arm (A) 40 mg/m(2) (n=17), arm (B) 50 mg/m(2) (n=17), arm (C) 60 mg/m(2) (n=19), arm (D) 50 mg/m(2) escalated by 10 mg/m(2) to a maximum of 70 mg/m(2) (n=19). Primary endpoints: maximum tolerated dose, RR, duration of response, symptom improvement, toxicity and QoL. Secondary endpoint: overall survival (OS). Patients and disease characteristics were well balanced. Median age was 67 (range 45-81), there were 32 male and 41 female, histology subtype: squamous/adenocarcinoma/mixed/NOS=42%/49%/4%/5%. RESULTS: Seven patients did not receive any treatment because of deterioration in PS or death. 50% of patients in arm D, who received more than one cycle, received dose escalation. There was no statistical difference in the number of cycles administered (arms A, B and D: median 2 cycles and arm C: median 3 cycles) and no difference in RR: arm A=6%, arm B=6%, arm C=10%, and arm D=0%. There was no statistically significant difference in grade 3/4 neutropenia and thrombocytopenia between the four arms. No difference was observed in hospitalization rate, blood transfusions, antibiotics administration and non-haematological toxicity. QoL: no difference in total scores between baseline and cycles 1-4. There was a significant decrease in pain scores from baseline to post cycles 2 and 3 (p=0.025 and p=0.002, respectively). There was no difference in OS (p=0.992). Median survival and 6-month survival were 61, 86, 88 and 97 days and 29%, 33%, 21% and 26% for arms A, B, C, and D, respectively. CONCLUSIONS: Clinical efficacy of docetaxel was observed at all dose levels. Higher dose levels were not associated with increased toxicities, use of IV antibiotics or hospitalization rates. However, the median survival observed is shorter than historical data and do not support further evaluation of these doses of single agent docetaxel in this population.