Observational, prospective, phase 4 study in patients with first-line recurrent and/or metastatic squamous cell carcinoma of the head and neck treated with cetuximab and platinum-based therapy: DIRECT.

BACKGROUND: Cetuximab plus platinum-based therapy (PBT) followed by cetuximab maintenance until progression (EXTREME) is a guideline-recommended first-line treatment option in recurrent/metastatic squamous cell carcinoma of the head and neck (R/M SCCHN). DIRECT (Dose Intensity RElative to CeTuximab) was the first phase 4 observational study evaluating EXTREME administration in the real-world setting. AIMS: The primary aim of this study was to assess the relative dose intensity of cetuximab in patients with R/M SCCHN treated with first-line cetuximab according to the EXTREME regimen. METHODS AND RESULTS: Patients were ≥18 years old and eligible to receive cetuximab/PBT. Primary endpoint was cetuximab relative dose intensity (RDI). Of prospectively enrolled patients (n = 157), 119 received ≥1 cycle of EXTREME. Practices differing from the EXTREME trial were 5-fluorouracil omission (14%), maintenance cetuximab given every other week (54%), prior cetuximab, disease-free interval <6 months. 64% of patients reached cetuximab RDI ≥80%; mean cetuximab RDI was 88%. 46% of patients received maintenance cetuximab (mean RDI, 91%). Median progression-free survival and overall survival were 4.5 and 9.4 months. No new/unexpected safety findings were observed. CONCLUSIONS: The DIRECT study showed that first-line cetuximab plus PBT was a feasible, beneficial first-line treatment regimen in patients with R/M SCCHN in the real-world setting.

A prospective observational study assessing home parenteral nutrition in patients with gastrointestinal cancer: benefits for quality of life.

CONTEXT: Patients with gastrointestinal cancer are at high risk for deterioration of nutrition. Home parenteral nutrition (HPN) could improve nutritional status and quality of life (QoL). OBJECTIVES: The purpose of this study was 1) to evaluate the impact of HPN on QoL, 2) to assess changes in nutritional status, and 3) to assess proxy perception of patient well-being. METHODS: We conducted a prospective, observational, and a multicenter study. Inclusion criteria were adult patients with gastrointestinal cancer, for whom HPN was indicated and prescribed for at least 14 days. The physician, the patient, and a family member completed questionnaires at inclusion and 28 days later. The QoL was assessed by the patients using the Functional Assessment of Cancer Therapy-General questionnaire, at inclusion and 28 days later. RESULTS: The study included 370 patients with gastrointestinal cancer. The HPN was indicated for cancer-related undernutrition in 89% of the patients and was used as a complement to oral intake in 84%. After 28 days of parenteral intake, global QoL was significantly increased (48.9 at inclusion vs. 50.3, P=0.007). The patients' weight improved significantly by 2.7% (P<0.001). The nutrition risk screening also decreased significantly (3.2±1.1 vs. 2.8±1.3, P=0.003). CONCLUSION: HPN could provide benefit for malnourished patients with gastrointestinal cancer. However, randomized controlled studies are required to confirm this benefit and the safety profile.

[Home parenteral nutrition in elderly patients with cancer: an observational prospective study]. / Nutrition parentérale à domicile chez la personne âgée atteinte d'un cancer: une étude observationnelle prospective.

Malnutrition is a bad prognostic factor that reduces the quality of life (QoL) in patients with cancer. The objective was to assess the impact of home parenteral nutrition (HPN) on the QoL of elderly malnourished patients with cancer. This French prospective observational study included patients, aged 70 years or older, with cancer, for whom HPN was prescribed for at least 14 days. The patient, the physician and a family member or home caregiver had to fill in a questionnaire at inclusion and 28 days later. Included patients (n = 221) were mainly suffering from a digestive cancer. After HPN intake, improved weight was noticed in 68% and 14% of patients had reached the target weight. Improved global QoL was reported in 59% of patients. Physicians noticed a significant improvement for the same compounds. These results suggest a benefit of the HPN on the nutritional status and QoL in elderly patients with cancer. Further controlled randomised trials are needed to prove the benefit of HPN in the routine management of these patients.

Granocyte-colony stimulating factor (G-CSF) has significant efficacy as secondary prophylaxis of chemotherapy-induced neutropenia in patients with solid tumors: results of a prospective study.

AIM: To carry out a prospective, multicenter and observational study describing prophylactic strategies [cycle delay, dose-reduction, (G-CSF) prescription] to prevent recurrence of neutropenic events (NE) in patients with solid tumors, and identify potential predictive factors of NE recurrence. PATIENTS AND METHODS: Patients ≥18 years old with an NE in a previous chemotherapy cycle (cycle A) without G-CSF support, followed for four cycles (B to E) were included in the study. NE was defined as any neutropenia grade 1-4, febrile or not, which impacted on subsequent chemotherapy cycles (cycle delay, or reduction, or prophylactic G-CSF). RESULTS: Data of 548 patients were analyzed, 378 (69%) were female, with a mean (SD) age of 61.7 (12.3) years. WHO PS: 0-1: 88.3%, incidence of breast cancer: 40%, metastatic disease: 53.3%. Following the first NE episode, 44.5% of patients had cycle delay, 22.3% dose reduction and 466 (85%) received prophylactic G-CSF. NE recurrence rates were: 21.2% at cycle B, 18.6% at cycle C, 11.5% at cycle D and 12.9% at cycle E. G-CSF support (hazard ratio: 0.32, 0.24-0.43, p<0.001) was associated with lower NE recurrence. Pegfilgrastim seemed to offer the highest protection (hazard ratio; HR=0.23, 95% CI: 0.16-0.32; p<0.001). CONCLUSION: Secondary G-CSF prophylaxis has significant efficacy in reducing the incidence of NE and should be considered as a valuable option.