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Background: Bevacizumab (Avastin®), a recombinant humanized monoclonal antibody, in combination with platinum-doublet chemotherapy has become a routine treatment for advanced non-small-cell lung cancer (NSCLC). The post-authorization, non-interventional study 'AVAiLABLE' assessed the effectiveness and safety of bevacizumab combined with chemotherapy as first-line treatment., Methods: Nine hundred and eighty-seven adult patients (mean age 61.5 years, 59.8% male) with non-resectable advanced, metastatic or recurrent, predominantly non-squamous NSCLC were evaluated at 185 sites across Germany. 72.8% of the patients had stage IV disease at start of observation, 90.1% had histologically confirmed adenocarcinoma and 80.8% met the bevacizumab label 'NSCLC other than predominantly squamous cell histology'. According to bevacizumab label, chemotherapy plus bevacizumab was recommended, followed by bevacizumab maintenance therapy. Effectiveness endpoints included response rates and progression-free survival (PFS); safety endpoints comprised adverse drug reactions (ADRs). Patients were followed until progression or intolerable toxicity. Data were evaluated by descriptive statistical methods., Results: Median PFS was 7.4 months (95% CI: 7.1; 8.4), overall response rate (ORR) 45.6% and disease control rate (DCR) 75%. The majority of patients (72.7%) achieved partial response or stable disease. Complete response was reached by 2.3%. 33.6% of patients experienced an ADR of grade ≥ 3. Bevacizumab-related ADRs of grade ≥ 3 occurred in 5.7% of patients, with the highest incidence for leukopenia, neutropenia, and hypertension., Conclusions: Results of the non-interventional study 'AVAiLABLE' confirmed the effectiveness and safety of bevacizumab in combination with platinum-based chemotherapy as first-line treatment for advanced NSCLC in accordance with previous studies. No new safety signals were identified. Maintenance therapy with bevacizumab was well tolerated and safe even over extended periods (> 20 cycles)., Trial Registration: ClinicalTrials.gov Identifier: NCT02596958; registered on 4 November 2015.

Purpose: The controlled phase III trial SATURN demonstrated that maintenance therapy with erlotinib after the first-line platinum-based chemotherapy prolonged progression-free survival (PFS) and overall survival (OS) of non-small cell lung cancer (NSCLC) patients with advanced, non-progressive disease. We conducted the non-interventional study SATURN NIS to investigate the effectiveness and tolerability of erlotinib maintenance in daily clinical practice., Methods: This single-arm NIS screened 290 patients with locally advanced or metastatic NSCLC (stage IIIB or IV) and stable disease after standard platinum-based first-line chemotherapy in 95 institutions across Germany. Erlotinib was dosed and administered corresponding to the terms of the marketing authorization at the time of recruitment. The main effectiveness endpoint was subjects' OS at 1 year. Subgroup analyses of survival estimates of OS and PFS were performed., Results: 272 patients were eligible for analysis (median age 66 years, 37.1% females, 99.6% Caucasian, median ECOG performance status 1, 61.8% adenocarcinoma, 96.3% of patients with stable disease). Maintenance therapy with erlotinib resulted in median OS comparable to that of the SATURN phase III trial 10.4 months [95% CI: (8.8; 12.5) vs. 11.9 months]. The 1-year survival rate was 45.6% [95% CI: (37.5%; 53.6%)]. No new safety signals were observed. As expected, patients with epidermal growth factor receptor (EGFR) mutations derived a greater benefit concerning OS and PFS than EGFR-wild-type patients. Moreover, a significant association of OS and PFS and the smoking status was observed., Conclusions: The results of this non-interventional study support the current clinical practice of erlotinib switch maintenance in EGFR-mutation-positive patients.

Objectives: Real-life data on advanced non-small cell lung cancer (NSCLC) are centrally important to complement the results from clinical trials and to improve the standard of care. We present data on the choice of systemic first- and second-line treatment, number of treatment lines, survival and longitudinal data on health-related quality of life (HRQOL) of patients treated by medical oncologists in Germany., Materials and Methods: 1239 patients with advanced NSCLC were recruited at start of first-line therapy into the prospective German clinical cohort study TLK (Tumour Registry Lung Cancer) by 107 sites between February 2010 and December 2013 and followed-up until January 2016. HRQOL was assessed using the EORTC QLQ-C30 and LC13 questionnaires., Results: Most patients receive carboplatin- or cisplatin-based doublet chemotherapy in first-line treatment. The choice of platinum agent did neither influence the outcome: median overall survival (OS) was 12.2 months for carboplatin combinations (95% confidence interval [CI] 10.0-13.8) and 11.9 months for cisplatin combinations (95% CI 10.2-13.8), nor did it have a marked impact on the HRQOL. Patients receiving cisplatin were younger and fitter at start of therapy than patients receiving carboplatin or mono-chemotherapy. The longitudinal HRQOL analysis revealed the main symptoms that need to be addressed in follow-up care, irrespective of the platinum agent: fatigue, nausea, dyspnoea and pain. The patients receiving targeted therapies with tyrosine kinase inhibitors (TKIs) had a median OS of 22.1 months (95% CI 15.0-35.1) and considerably superior HRQOL., Conclusion: There was no difference in outcome between the platinum compounds cisplatin and carboplatin in first-line treatment of advanced NSCLC in routine care. This is the first report of longitudinal HRQOL data comparing treatments, showing no difference between carboplatin and cisplatin., (Copyright © 2017 The Authors. Published by Elsevier B.V. All rights reserved.)

Tauromustine (TCNU) is a newly developed nitrosourea compound. As a result of molecular modification, TCNU is more hydrophilic than BCNU and CCNU. In experimental data there was a high therapeutic index, especially in Walker 256 carcinosarcoma in rats, and in phase I trials antitumor activity was observed in NSCLC (10/33 remissions). There was also activity in melanoma, breast cancer, pleuramesotheliomas and ovarian cancer. To determine the effectiveness, duration of response and toxicity of TCNU the following phase II trial was performed. Patients received 130 mg/m2 TCNU every 35 days orally. Twenty-five patients were treated; 22 were evaluable. The female/male ratio was 18/4, 1 patient was stage III, 21 patients stage IV, the mean age was 62.3 years (range 32-70). Between 1 and 4 courses (mean 1.9) were administered. Histology was as follows: 6 squamous cell, 11 adenocarcinoma, 2 large cell and 3 polymorph cell carcinomas. No objective response (CR + PR) was observed; 6/18 patients had stable disease, 7/18 progression and 5/18 early progression. The median survival time is 4.9 months. The most severe side effect was thrombocytopenia (WHO grade 3 + 4, 4/22 patients). TCNU administered at this dose and schedule does not show substantial antitumor activity in patients with NSCLC. The fact that no objective tumor remission was observed suggests that the true response rate is less than 20% (p less than 0.05). It is improbable that TCNU has a relevant impact on the course of inoperable NSCLC.

192 untreated patients with a histologically verified non-small cell lung carcinoma were treated within 3 phase-II studies with different chemotherapy regimens: ifosfamide 2 g/m2 day 1-5 and cis-platinum 75 mg/m2 on day 1 (study I); ifosfamide 2 g/m2 days 1-5 and etoposide 120 mg/m2 days 1-3 (study II); ifosfamide 2 g/m2 days 1-5 and vindesine 3 mg/m2 on days 1 and 8 (study III). All chemotherapy combinations were repeated every 4 weeks. One therapy with at least 2 courses was the minimum criterion for evaluating the remission rate. We observed complete remissions in 5 patients, and partial remissions in 54 patients (remission rate 31%). The median duration of remission was 7 months, the time to progression 5 months. The median survival time of all 192 patients was calculated as 8.5 months. The performance status had a significant influence on the remission state and the survival time of the patients. The sex and age of the patients as well as the extension and the histological type of the tumor had no influence. Concerning the remission rate and the survival time, there was no significant difference between the 3 therapy regimens. Due to the lesser toxicity, the combination ifosfamide/etoposide was the best.