Randomized phase III trial of gemcitabine and cisplatin vs. gemcitabine alone in patients with advanced non-small cell lung cancer and a performance status of 2: The CAPPA-2 study

What can platinum offer yet in the treatment of PS2 NSCLC patients? A systematic review and meta-analysis

“…The results of these trials suggest that platinum-based combination regimens are superior to singleagent chemotherapy in the first-line treatment of this special population both in terms of ORR and 1y-SR, despite an increase in severe haematological toxicities. This literature-based meta-analysis confirms the results achieved in the randomized trials devoted to PS 2 patients [18,19].…”

“…Five publications [18,19,[21][22][23] are about randomized phase III trials and one was a randomized phase II trial [24]. Four studies [18,19,21,24] were specifically devoted to PS2 patients, while two trials [22,25] reported subgroup analysis for PS2 patients (18 and 20%, respectively) within larger randomized phase III trials.…”

“…Four studies [18,19,21,24] were specifically devoted to PS2 patients, while two trials [22,25] reported subgroup analysis for PS2 patients (18 and 20%, respectively) within larger randomized phase III trials. All trials compared a platinumbased doublet with single-agent chemotherapy; four of these [18,21,22,24] compared carboplatin-based doublet with single agent chemotherapy: carboplatin plus pemetrexed vs pemetrexed alone [18], carboplatin plus gemcitabine vs gemcitabine alone [21,24], carboplatin plus paclitaxel vs paclitaxel alone [22,25]; the other two trials compared cisplatin plus gemcitabine with gemcitabine alone [19] and cisplatin plus vinorelbine or vindesine with vinorelbine alone [23]. In nearly every trial characteristics were well balanced between two arms.…”

“…The extracted data, including number of patients, PS, age, histology, stage, chemotherapy regimens, and outcomes, were reported in Table 2. Data about ORR [18,19,21,22,24] and 1y-SR [18,[21][22][23][24] were available from five studies. Finally, data about toxicity were available from 4 trials [18,19,21,24].…”

“…However, in the last years, new prospective randomized phase III trials have been performed to evaluate the efficacy and tolerability of platinum-based doublet chemotherapy compared to single agent in this subset of patients, revealing unexpected results [18,19].…”