387 Background: This Phase 1 study (NCT01938612) evaluated D (anti-PD-L1 mAb) and T (anti-CTLA-4 mAb) in Asian pts, in whom optimal dosing of D and T is undetermined. No dose-limiting toxicities were observed, and durable responses were seen in a dose escalation phase evaluating various D doses and regimens in Japanese pts (Iguchi, ASCO 2015). The study was subsequently expanded to larger cohorts of Asian pts with advanced solid tumors including BTC. Methods: Two regimens were selected for the expansion phase: D monotherapy (10 mg/kg q2w) and D+T (D 20 mg/kg + T 1.0 mg/kg q4w). One cohort of pts with advanced BTC was enrolled to receive D monotherapy followed by a separate cohort that received D+T with additional pts enrolled if efficacy was observed. Safety, response, and survival endpoints were based on investigator assessment. Results: Pts were enrolled to D (N = 42) or D+T (N = 65). Median age was 64 years for the D cohort and 62 years for the D+T cohort, the majority were male, and ECOG PS was 0 or 1: 64% and 36% for pts in the D cohort and 49% and 51% for pts in the D+T cohort, respectively. Median number of prior chemotherapy regimens was 2 for both cohorts. Treatment-related adverse events (trAE) of any grade occurred in 64% and 82% of pts in the D and D+T cohorts. Grade ≥ 3 trAEs occurred in 19% and 23% of pts in the D and D+T cohorts. trAEs led to discontinuation in 2 pts in the D cohort and 5 pts in the D+T cohort. A death due to trAE (drug-induced liver injury) was reported in the D+T cohort, none in the D cohort. In the D cohort, 2 pts had a partial response (PR) and 7 pts had a PR in the D+T cohort; disease control rate at 12 weeks was 16.7% and 32.2%, respectively. Median duration of response for the D cohort was 9.7 months and 8.5 months for the D+T cohort. Median overall survival was 8.1 (95% CI, 5.6-10.1) months and 10.1 (95% CI, 6.2-11.4) months for the D and D+T cohorts, respectively. Conclusions: Both D monotherapy and D+T combination therapy were tolerable for Asian pts with BTC, and no unexpected toxicities were observed with either regimen. Promising clinical benefit was observed with both D and D+T therapy. This study provides valuable information regarding these therapeutic regimens for future studies in pts with BTC. Clinical trial information: NCT01938612.

Background: Diagnostic bronchoscopy has been considered as a safe and effective procedure. Endobronchial ultrasound with a guide sheath (EBUS-GS) for the diagnosis of peripheral pulmonary lesions (PPLs) is becoming a common procedure, but reports about its safety are missing. Objectives: The aim of this study was to evaluate the safety profile of EBUS-GS for the diagnosis of PPLs. Methods: All patients with PPLs who underwent EBUS-GS between September 2012 and August 2014 at the National Cancer Center Hospital were included. Postprocedural complications and the durability of devices were retrospectively reviewed. Results: During the study period, EBUS-GS procedures were performed for 965 PPLs. The overall complication rate was 1.3% (13/965): 0.8% (8/965) for pneumothorax and 0.5% (5/965) for pulmonary infection. There was no significant hemorrhage, air embolism, tumor seeding or procedure-related death, and there was no breakage of the guide sheath. Only four radial probes were broken during the study period without any adverse reactions. Conclusions: EBUS-GS is a tolerable procedure, and the devices are durable.

Background Agents targeting the programmed cell death‐1 pathway have demonstrated encouraging activity across multiple solid tumor types. The dose expansion phase of this phase I study evaluated the safety, tolerability, and antitumor activity of durvalumab monotherapy, and durvalumab plus tremelimumab (an anti‐cytotoxic T‐lymphocyte‐associated antigen 4 monoclonal antibody) combination therapy, in patients from Asia with biliary tract cancer (BTC), esophageal squamous cell carcinoma (ESCC), or head and neck squamous cell carcinoma (HNSCC). Methods Patients with advanced BTC, ESCC, or HNSCC with disease progression during or following ≥1 platinum‐based therapy received durvalumab monotherapy (10 mg/kg every 2 weeks) or durvalumab plus tremelimumab (durvalumab 20 mg/kg every 4 weeks [Q4W] plus tremelimumab 1 mg/kg Q4W for 4 doses, followed by durvalumab 20 mg/kg Q4W). The primary objective was safety and tolerability. Secondary objectives included antitumor activity. Results Durvalumab monotherapy was assessed in 116 patients (median age 63.5 years, 75.9% male) of whom, 42, 42, and 32 had BTC, ESCC, or HNSCC, respectively. Grade ≥3 treatment‐related adverse events (TRAEs) were reported in 19.0%, 9.5%, and 25.0% of patients with BTC, ESCC, and HNSCC, respectively. Objective response rate (ORR) was 4.8%, 7.1%, and 9.4% in BTC, ESCC, and HNSCC. Durvalumab plus tremelimumab was evaluated in 124 patients (median age 62.0 years, 79.8% male) of whom 65 had BTC and 59 had ESCC. Grade ≥3 TRAEs were reported in 23.1% and 13.6% of patients with BTC and ESCC. ORR was 10.8% and 20.3% in BTC and ESCC. There were two complete responses and 10 partial responses in ESCC, and seven partial responses in BTC. Conclusion In general, durvalumab monotherapy and durvalumab plus tremelimumab combination therapy displayed acceptable safety profiles consistent with published literature, and also demonstrated clinical benefit, in patients from Asia with BTC, ESCC, or HNSCC with disease progression on ≥1 prior treatment. ClinicalTrials.gov Identifier: NCT01938612.

GS-TBNA is a safe technique for PPL diagnosis and may be useful when the EBUS probe cannot reach the lesion.

Forceps biopsy is an important sampling method during endobronchial ultrasound with a guide sheath for peripheral pulmonary lesions. In the collection of diagnostic liquid samples, guide sheath flush is more advantageous than bronchial lavage and provides specimen that may be adequate for molecular testing.