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Introduction The real-world effectiveness of combination treatment with cytotoxic chemotherapy and programmed cell death protein-1 or programmed death-ligand 1 inhibitor for NSCLC, especially for the elderly (aged ≥75 y) or those with poor performance status (≥2), has not been fully elucidated. We investigated the real-world effectiveness and safety of this combination therapy in these populations. Methods This multicenter retrospective study evaluated patients who are chemo-naïve with advanced NSCLC who received a combination of platinum, pemetrexed, and pembrolizumab between December 2018 and June 2019. This was an updated prespecified secondary analysis with the primary objective of investigating the safety and effectiveness in this cohort. Results Overall, 299 patients were included. Multivariate analysis identified performance status (0–1) and programmed death-ligand 1 tumor proportion score (≥50%) as significant independent predictors of progression-free survival ( p = 0.007, and p = 0.003, respectively). The incidence of severe adverse events (AEs) was higher in the elderly and those with poor performance status than in their younger and good performance status counterparts. A total of 71 patients developed AEs that led to treatment discontinuation, and AE-related treatment discontinuation occurred at a significantly higher rate in older patients (median [range]) (70 [46–82] y) than in younger patients (68 [31–84] y) ( p <0.001). Conclusions Combination treatment with pembrolizumab plus chemotherapy had low real-world effectiveness for poor performance status patients. Severe AEs occurred at a higher rate in the elderly and poor performance status patients, and the AE-related treatment discontinuation rate increased with age. Physicians should be cautious about using this regimen, especially in the elderly and poor performance status patients.

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Background: Human fibroblast growth factor-2 (rhFGF-2) therapy has been used for periodontal tissue regeneration. However, few studies have reported their adjunctive procedures based on strategy of tissue engineering. The aim of this retrospective study is to assess the adjunctive effects of modified papilla preservation technique (mPPT) and combination with autogenous bone grafts (AG) on the rhFGF-2 therapy. Methods: Total of 44 sites underwent rhFGF-2 therapies and the evaluations in the survey periods. The primary outcome was set to the radiographic bone fill by radiographic examinations at 6 and 12 months after surgeries. We analyzed the correlation between influencing factors and the primary outcome, and differences of therapeutic effect by combination therapy with mPPT and that with AG.Results: After surgeries, probing depth (PD), clinical attachment level (CAL) and bone defects significantly improved. The improvements of radiographic bone fill were significantly positive correlated with a number of bone walls, combination with mPPT, and AG at 6 months after surgeries, and with combination with mPPT and AG at 12 months after surgeries. The significant differences of improvements of radiographic bone fill were demonstrated between combination with or without mPPT at 12 months after surgeries, and with or without AG at 6 and 12 months after surgeries. Moreover, the multiple linear regression analysis for the radiographic bone fill indicated the significant regression coefficient with conducts of mPPT. Conclusions: mPPT and AG had powerfully adjunctive effects on rhFGF-2 therapy. Further studies are needed in order to verify by randomized clinical trials.

Background: The aim of this study was to evaluate the efficacy and safety of nab-paclitaxel plus cisplatin in chemotherapy-naïve patients with advanced non-small-cell lung cancer (NSCLC).Methods: Chemotherapy-naïve patients with advanced NSCLC were eligible. In the phase I dose-escalation cohort (3 + 3 design), patients received nab-paclitaxel (80 or 100 mg/m 2 given intravenously on days 1, 8 and 15) plus cisplatin (60 or 75 mg/m 2 given intravenously on day 1) every 4 weeks. The maximum tolerated dose was not reached. Nab-paclitaxel (100 mg/m 2 given intravenously on days 1, 8 and 15) plus cisplatin (75 mg/m 2 given intravenously on day 1) every 4 weeks was selected for the phase II cohort. The primary endpoint was the objective response rate (ORR).Results: Twenty-three patients (phase I, n = 6; phase II, n = 17) were enrolled, and 22 patients were eligible. The median age was 67.5 years (range 37-75), 90.9% were males, 45.5% had adenocarcinoma and 81.8% had stage IV disease. The ORR was 59.1% (90% confidence interval (CI); 41.8-74.4), and the disease control rate was 86.4% (95% CI; 66.7-95.3). The median progression-free survival was 5.1 months (95% CI; 4.0-6.7), and the median overall survival was 24.2 months (95% CI; 8.4 months to not estimable). The common grade ≥ 3 adverse events were neutropenia (31.8%), leukopenia (27.3%), lung infection (18.2%) and hyponatremia (18.2%). There was one instance of grade 2 interstitial pneumonia and no treatment-related death. Conclusions: Nab-paclitaxel plus cisplatin was well tolerated and associated with encouraging response outcomes in chemotherapy-naïve patients with advanced NSCLC. Further investigation is warranted.

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Background: Nab-Paclitaxel plus gemcitabine significantly improved overall survival, progression-free survival, and response rate in patients with metastatic pancreatic adenocarcinoma. Combination treatment increases intra-tumoral gemcitabine levels attributable to a decrease in the primary gemcitabine metabolizing enzyme, cytidine deaminase. Based on these data, we planned to assess the efficacy and safety of combination with nab-PTX + gemcitabine in patients with non-smallcell lung cancer (NSCLC) previously treated with platinum based chemotherapy. Methods: Patients with advanced NSCLC with progressive disease to platinum-based chemotherapy, ECOG performance status (PS) 0 or 1, and adequate kidney, liver and bone marrow function were eligible. Treatment consisted of nab-paclitaxel (100 mg/m 2) + gemcitabine (1000 mg/m 2) on days 1 and 8 of each 3-week cycle until progression disease or unacceptable toxicity. The primary endpoint was progression-free survival (PFS). Results: Of the 28 patients enrolled, 28 were evaluable for response and toxicity. The median age was 68 years (range 47-79), 23 male and 5 female. Histology subtypes were: adenocarcinoma 19 patients, squamous cell carcinoma 9 patients. Seventeen patients had ECOG PS 1 and 11 patients had PS 0. Twenty-four patients were 2 nd line and 4 patients were 3 rd line. The median number of cycles administered was 4(range 1-10). The overall response rate was 17.9%. The disease control rate was 67.9%. The median progression-free survival was 3.3 months (95% confidence interval [CI] = 1.6-4.7). Four patients (14.3%) had grade 3 anemia, 3 patients (10.7%) had grade 3 thrombocytopenia, 5 patients (17.9%) had grade 4 neutropenia. However, no patients developed febrile neutropenia. Remarkable non-hematologic toxicity was interstitial pneumonia with grade 3 in 4 patients (14.3%), neuropathy with grade 1 in 2 patients (7.1%) and infections with grade 3 in 2 patients (7.1%). Conclusions: The efficacy of nab-Paclitaxel in combination with gemcitabine in advanced second or third-line NSCLC patients was limited and the high onset of interstitial pneumonia was unacceptable.