High Response Rate to Carboplatin-Paclitaxel-Cetuximab and Pembrolizumab in Patients with Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma.

The management of R/M HNSCC is rapidly evolving with new available treatment molecules and combination modalities. Anti-EGFR cetuximab (CTX) and immune checkpoint inhibitors (ICI) can be used either alone or in combination with conventional platinum-based doublet chemotherapy (with taxanes or fluorouracil). No data have been reported to date on the association of doublet chemotherapy concomitantly with both CTX and ICI. We present a case series of patients treated with 4 cycles of quadritherapy, every 3 weeks, including paclitaxel 175 mg/m2, carboplatin AUC 5, pembrolizumab 200 mg, and weekly 250 mg/m2 CTX. All patients achieved an objective response (6 complete responses, 2 partial responses). Clinical response was fast, so 1 patient avoided an emergency tracheostomy for laryngeal dyspnea. Four patients furtherly benefited from cisplatin-based chemoradiotherapy on residual tumor sites after the response to quadritherapy. Adverse events were manageable, except for an ICI-related liver toxicity in a patient. Overall, this short series indicates that a quadruple therapy with carboplatin-paclitaxel-CTX and pembrolizumab seems to be safe and active in patients with R/M HNSCC. This observation could be confirmed through further clinical trials.

G-CSF filgrastim biosimilar-Sandoz reduces the incidence of febrile neutropenia in patients receiving chemotherapy regimens with rest periods not exceeding 14 days: A French, multicenter, prospective, non-interventional study.

PURPOSE: The objective of this study was to describe filgrastim biosimilar-Sandoz modalities of use in patients receiving cytotoxic chemotherapy regimens with a rest period of ≤14 days and to investigate the incidence of febrile neutropenia (FN) in routine clinical practice. METHODS: This was a French, multicenter, prospective and descriptive, non-interventional study including patients with breast, lung, gastrointestinal cancer or a lymphoma initiating filgrastim biosimilar-Sandoz treatment and in the context of cytotoxic chemotherapy with a rest period not exceeding 14 days. Data were collected during two routine clinical visits on the modalities of use of filgrastim biosimilar-Sandoz, on the incidence of neutropenia events and on adverse events. RESULTS: Between November 2015 and June 2018, 1080 patients were enrolled in the study in 129 centers. Overall, 941 patients were evaluable for efficacy and 937 for safety. Of the 941 patients, 84.8% had a solid tumor and 15.2% had a lymphoid hemopathy. Filgrastim biosimilar-Sandoz was prescribed as primary prophylaxis in 74.0% of the patients and as secondary prophylaxis in 22.4% of the patients. FN was reported in 1.5% of patients with a solid tumor and 12.6% of patients with a lymphoma. A chemotherapy relative dose intensity of over 85% with regard to the reference dose was achieved by more than 80% of the patients in all tumor localizations. CONCLUSIONS: The study showed that filgrastim biosimilar-Sandoz is safe to use and effective in preventing FN and in allowing to maintain the dose intensity of chemotherapy.

Resection of small bowel adenocarcinoma metastases: Results of the ARCAD-NADEGE cohort study.

INTRODUCTION: Data are lacking with regard to curative resection of metastasis from small bowel adenocarcinoma (SBA). This study evaluated outcomes and prognostic factors in patients with curatively resected metastatic SBA. METHODS: A series of 34 patients undergoing resection of metastatic SBA from January 2009 to November 2014 at French centers were included into this cohort study. The primary endpoint was overall survival (OS). Secondary endpoints were recurrence-free survival (RFS) and prognostic factors. Univariate analyses were performed to determine prognostic risk factors. RESULTS: The sites of SBA metastases were peritoneal (29.4%), liver (26.5%), lymph nodes (11.8%), lung (2.9%), multiple (14.7%), and other (14.7%). Thirty (88.2%) patients received adjuvant or perioperative chemotherapy, mainly was oxaliplatin-based (76.5%). The median OS was 28.6 months and RFS was 18.7 months. Fourteen (41.2%) patients survived for more than 36 months. In univariate analysis, poor differentiation (P = 0.006), invaded margins (P = 0.003), and lymphatic invasion in the primary tumor (P = 0.039) were associated with decreased OS. CONCLUSION: Overall survival of patients after resection of metastatic SBA remains poor, but long-term survivors are observed. Resection of metastatic SBA should be consider if patients are expected to be operated on with curative intent and have moderately or well-differentiated tumors.

Intra-Arterial Delivery of Idarubicin in Two Patients with Glioblastoma.

There is no effective treatment for recurrent glioblastoma (GB) when temozolomide-based radiochemotherapy fails. In theory, intra-arterial (IA) delivery of cytotoxic agents could achieve higher drug concentrations in tumors compared to intravenous injection. Moreover, choosing a highly lipid-soluble drug could make the most of the first-pass effect. Here, we evaluated idarubicin (IDA), a lipophilic anthracycline, in an in vitro assay using four human GB cell lines and compared it with 11 other drugs previously used for the IA treatment of brain tumors. Despite impressive in vitro cytotoxicity, IA IDA did not produce a beneficial effect in 2 patients with recurrent GB.