Phase 2, open-label, 1:1 randomized controlled trial exploring the efficacy of EMD 1201081 in combination with cetuximab in second-line cetuximab-naïve patients with recurrent or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN).

AIM: To determine whether EMD 1201081, a TLR9 agonist, added to cetuximab had antitumor activity in second-line recurrent/metastatic squamous cell carcinoma of the head and neck (R/M SCCHN). METHODS: This was a phase 2, open-label, randomized trial of EMD 1201081 0.32 mg/kg subcutaneously weekly plus cetuximab (combination) vs cetuximab monotherapy (control) in cetuximab-naïve patients with R/M SCCHN who progressed on 1 cytotoxic regimen. Crossover to combination was permitted after progression. RESULTS: Objective response rate in both arms was 5.7% (95% CI 1.2-15.7%) by independent assessment. Disease control was 37.7% for patients on combination (24.8-52.1%) and 43.4% on control (29.8-57.7%). Neither independent nor investigator assessments showed significant differences between study arms. Median progression-free survival was 1.5 months (1.3-2.6) for patients on combination, and 1.9 months (1.5-2.9) on control. The most frequent adverse events in the combination arm were rash (29.6%), acneiform dermatitis (22.2%), and injection site reactions (20.4%). Grade 3/4 dyspnea and hypokalemia were more frequent with cetuximab monotherapy (7.5% and 5.7% vs 1.9% each, respectively), and grade 3/4 respiratory failure and disease progression were more frequent with combination (5.6% each vs 1.9% each). CONCLUSION: EMD 1201081 was well tolerated combined with cetuximab, but there was no incremental clinical efficacy.

Prognostic factors in patients with advanced non-small cell lung cancer: data from the phase III FLEX study.

The FLEX study demonstrated that the addition of cetuximab to chemotherapy significantly improved overall survival in the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC). In the FLEX intention to treat (ITT) population, we investigated the prognostic significance of particular baseline characteristics. Individual patient data from the treatment arms of the ITT population of the FLEX study were combined. Univariable and multivariable Cox regression models were used to investigate variables with potential prognostic value. The ITT population comprised 1125 patients. In the univariable analysis, longer median survival times were apparent for females compared with males (12.7 vs 9.3 months); patients with an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 compared with 1 compared with 2 (13.5 vs 10.6 vs 5.9 months); never smokers compared with former smokers compared with current smokers (14.6 vs 11.1 vs 9.0); Asians compared with Caucasians (19.5 vs 9.6 months); patients with adenocarcinoma compared with squamous cell carcinoma (12.4 vs 9.3 months) and those with metastases to one site compared with two sites compared with three or more sites (12.4 months vs 9.8 months vs 6.4 months). Age (<65 vs ≥65 years), tumor stage (IIIB with pleural effusion vs IV) and percentage of tumor cells expressing EGFR (<40% vs ≥40%) were not identified as possible prognostic factors in relation to survival time. In multivariable analysis, a stepwise selection procedure identified age (<65 vs ≥65 years), gender, ECOG PS, smoking status, region, tumor histology, and number of organs involved as independent factors of prognostic value. In summary, in patients with advanced NSCLC enrolled in the FLEX study, and consistent with previous analyses, particular patient and disease characteristics at baseline were shown to be independent factors of prognostic value. The FLEX study is registered with ClinicalTrials.gov, number NCT00148798.

Height growth of adolescent German boys and girls.

Longitudinal annual height measurements of 46 boys and 47 girls from Dortmund, Germany, are used to derive 10 parameters concerning the adolescent growth spurt of height. Out of three mathematical models applied to our height data, model 1 of Preece and Baines (1978) proved most suitable. Data of mean heights at age 9 and 10 of the boys and girls of this study do not differ from those of another representative cross-sectional study of our institute. The values of the 10 parameters agree with the data of studies from other countries. This work contributes original German data to the international data on adolescent growth spurt of height.

[Breast feeding studies 1981-1983 in 1,500 mothers in Dortmund and Haltern. III. Rates of breast feeding and duration of breast feeding in the first half year]. / Stillstudien 1981-1983 bei 1500 Müttern in Dortmund und Haltern. III. Stillraten und Stilldauer im 1. Lebenshalbjahr.

With two collectives of mothers from the large maternity wards in Dortmund (n = 998) and Haltern (n = 500) breast-feeding patterns were studied prospectively after dismissal. 95 and 93% of initially breast-feeding mothers kept simple protocols of duration and intensity of breast-feeding. 20 and 13% respectively of the breast-feeding mothers in Dortmund and Haltern stopped breast-feeding within 3 days following discharge, only 2 and 6% respectively of all mothers fully breast-fed for a period of a months as recommended. Already from the beginning of the 2nd month some mothers introduced (unnecessarily) juices as Beikost. Reasons given by the mothers for termination of breast-feeding were mostly connected with problems concerning the mother (50%) and nursing problems (35%). Statistical analysis (Cox proportional hazards model) revealed that the mothers' age (less than 25 years), low educational level, bad breast-feeding experience and use of a pump significantly reduce duration of breast-feeding. Promotion and support of breast-feeding is urgently needed especially during the first weeks after birth and with inexperienced, young and less educated mothers.