Domenico Galetta1, Saverio Cinieri2, Salvatore Pisconti3, Vittorio Gebbia4, Alessandro Morabito5, Nicola Borsellino6, Evaristo Maiello7, Antonio Febbraro8, Annamaria Catino9, Pietro Rizzo2, Michele Montrone3, Andrea Misino9, Antonio Logroscino9, Daniele Rizzi10, Massimo Di Maio11, Giuseppe Colucci10. 1. Medical Oncology Unit, National Cancer Research Center "Giovanni Paolo II", Bari, Italy. Electronic address: galetta@teseo.it. 2. Medical Oncology Department and Breast Unit - "Sen. Perrino" Hospital Strada Statale 7 per Mesagne, Brindisi, Italy. 3. Medical Oncology Division, "S.G. Moscati" Hospital, Taranto, Italy. 4. Medical Oncology Division, "La Maddalena" Hospital, Palermo, Italy. 5. Thoraco-Pulmonary Medical Oncology, National Cancer Institute "Fondazione G. Pascale" - IRCCS, Napoli, Italy. 6. Medical Oncology Unit, "Buccheri-La Ferla" Hospital, Palermo, Italy. 7. Medical Oncology Division, "Casa Sollievo della Sofferenza" Hospital, Foggia, Italy. 8. Medical Oncology Division, "Fatebenefratelli" Hospital, Benevento, Italy. 9. Medical Oncology Unit, National Cancer Research Center "Giovanni Paolo II", Bari, Italy. 10. Gruppo Oncologico Italia Meridionale (GOIM), Bari, Italy. 11. Clinical Trials Unit, National Cancer Institute "Fondazione G. Pascale" - IRCCS, Napoli, Italy.
Abstract
INTRODUCTION:Cisplatin with pemetrexed (CP) and carboplatin with paclitaxel and bevacizumab (CbTB) are standard first-line treatments for patients with advanced nonsquamous (NS) non-small-cell lung cancer (NSCLC). Quality of life (QoL) is a key objective in the management of advanced NSCLC. Thus, effect on QoL could be an additional factor in the choice of treatment. PATIENTS AND METHODS: Patients with untreated stage IIIB/IV NS-NSCLC and Eastern Cooperative Oncology Group performance status of 0 or 1 were randomized to receive first-line chemotherapy with cisplatin 75 mg/m(2) and pemetrexed 500 mg/m(2), every 3 weeks, for 6 cycles followed by maintenance pemetrexed; or carboplatin area under the curve 6, paclitaxel 200 mg/m(2), and bevacizumab 15 mg/kg, every 3 weeks, for 6 cycles followed by maintenance bevacizumab. The primary end point was the difference in QoL between the 2 treatment arms after 12 weeks of maintenance, measured using the EuroQoL 5 Dimensions-Index (EQ5D-I) and EQ5D-visual analogue scale (EQ5D-VAS). RESULTS:One hundred eighteen patients were randomized to CP (n = 60) or CbTB (n = 58). Baseline characteristics were well balanced. The proportion of patients evaluable for the primary end point was lower than planned. After 12 weeks of maintenance, the difference between mean changes in EQ5D-I was 0.137, favoring CP (95% confidence interval [CI], -0.02 to 0.29, Wilcoxon P = .078), although not statistically significant; and the difference between mean changes in EQ5D-VAS was 0.97 (95% CI, -9.37 to 11.31, Wilcoxon P = .41). CONCLUSION: Although the study was underpowered because of a small number of patients evaluable for the primary end point, QoL did not differ between treatment arms. Other factors such as comorbidities and schedule should be used when deciding on first-line treatment.
RCT Entities:
INTRODUCTION:Cisplatin with pemetrexed (CP) and carboplatin with paclitaxel and bevacizumab (CbTB) are standard first-line treatments for patients with advanced nonsquamous (NS) non-small-cell lung cancer (NSCLC). Quality of life (QoL) is a key objective in the management of advanced NSCLC. Thus, effect on QoL could be an additional factor in the choice of treatment. PATIENTS AND METHODS: Patients with untreated stage IIIB/IV NS-NSCLC and Eastern Cooperative Oncology Group performance status of 0 or 1 were randomized to receive first-line chemotherapy with cisplatin 75 mg/m(2) and pemetrexed 500 mg/m(2), every 3 weeks, for 6 cycles followed by maintenance pemetrexed; or carboplatin area under the curve 6, paclitaxel 200 mg/m(2), and bevacizumab 15 mg/kg, every 3 weeks, for 6 cycles followed by maintenance bevacizumab. The primary end point was the difference in QoL between the 2 treatment arms after 12 weeks of maintenance, measured using the EuroQoL 5 Dimensions-Index (EQ5D-I) and EQ5D-visual analogue scale (EQ5D-VAS). RESULTS: One hundred eighteen patients were randomized to CP (n = 60) or CbTB (n = 58). Baseline characteristics were well balanced. The proportion of patients evaluable for the primary end point was lower than planned. After 12 weeks of maintenance, the difference between mean changes in EQ5D-I was 0.137, favoring CP (95% confidence interval [CI], -0.02 to 0.29, Wilcoxon P = .078), although not statistically significant; and the difference between mean changes in EQ5D-VAS was 0.97 (95% CI, -9.37 to 11.31, Wilcoxon P = .41). CONCLUSION: Although the study was underpowered because of a small number of patients evaluable for the primary end point, QoL did not differ between treatment arms. Other factors such as comorbidities and schedule should be used when deciding on first-line treatment.
Authors: Benjamin K Schneider; Arnaud Boyer; Joseph Ciccolini; Fabrice Barlesi; Kenneth Wang; Sebastien Benzekry; Jonathan P Mochel Journal: CPT Pharmacometrics Syst Pharmacol Date: 2019-05-09
Authors: Christine M Cramer-van der Welle; Bas J M Peters; Franz M N H Schramel; Olaf H Klungel; Harry J M Groen; Ewoudt M W van de Garde Journal: Eur Respir J Date: 2018-12-20 Impact factor: 16.671