Efficacy and safety of avelumab treatment in patients with metastatic Merkel cell carcinoma: experience from a global expanded access program

BackgroundAvelumab, a human anti–programmed death-ligand 1 immunoglobulin G1 monoclonal antibody, showed favorable efficacy and safety in patients with metastatic Merkel cell carcinoma (mMCC) in the phase II JAVELIN Merkel 200 trial, leading to approval in multiple countries. We describe real-world experience with avelumab in patients with mMCC from an expanded access program.MethodsEligible patients had mMCC and progressive disease during or after chemotherapy or were ineligible for chemotherapy or clinical trial participation. Patients received an initial 3-month supply of avelumab (administered as 10 mg/kg intravenously every 2 weeks until progressive disease or unacceptable toxicity); resupply was allowed following complete response, partial response, stable disease, or clinical benefit per physician assessment.ResultsBetween December 15, 2015, and March 4, 2019, 558 of 620 requests from 38 countries were medically approved, and 494 patients received avelumab. Among 240 evaluable patients, the objective response rate was 46.7% (complete response in 22.9%, including 3 of 16 potentially immunocompromised patients), and the disease control rate was 71.2%. The median duration of treatment in evaluable patients with response was 7.9 months (range, 1.0–41.7) overall and 5.2 months (range, 3.0–13.9) in immunocompromised patients. No new safety signals were identified. The expanded access program closed for new requests on December 31, 2018, as required after regulatory approval; benefitting patients continued to receive avelumab.ConclusionsThe avelumab expanded access program for patients with mMCC demonstrated efficacy and safety in a real-world setting, consistent with the results from JAVELIN Merkel 200, and provided a treatment for patients with limited options

Automatic localization of the prostatic urethra for image guided radiation therapy

Treatment of prostate cancer with radiation therapy (RT) requires image guided RT (IGRT) to focus the radiation on the target volumes while minimizing doses to organs at risk. Here we describe a urinary catheter that allows imaging of the prostatic urethra and uses it for automatic localization of the prostate for IGRT. The catheter has a contrast lumen that can be empty or full with contrast. Computerized tomography is performed twice, with contrast lumen empty and full, allowing urethral autosegmentation using digital subtraction. Under ultrasound, continuous urethral visualization is possible by pumping aerated gel in- and out of the contrast lumen

Efficacy and safety of avelumab treatment in patients with metastatic Merkel cell carcinoma: experience from a global expanded access program

BackgroundAvelumab, a human anti–programmed death-ligand 1 immunoglobulin G1 monoclonal antibody, showed favorable efficacy and safety in patients with metastatic Merkel cell carcinoma (mMCC) in the phase II JAVELIN Merkel 200 trial, leading to approval in multiple countries. We describe real-world experience with avelumab in patients with mMCC from an expanded access program.MethodsEligible patients had mMCC and progressive disease during or after chemotherapy or were ineligible for chemotherapy or clinical trial participation. Patients received an initial 3-month supply of avelumab (administered as 10 mg/kg intravenously every 2 weeks until progressive disease or unacceptable toxicity); resupply was allowed following complete response, partial response, stable disease, or clinical benefit per physician assessment.ResultsBetween December 15, 2015, and March 4, 2019, 558 of 620 requests from 38 countries were medically approved, and 494 patients received avelumab. Among 240 evaluable patients, the objective response rate was 46.7% (complete response in 22.9%, including 3 of 16 potentially immunocompromised patients), and the disease control rate was 71.2%. The median duration of treatment in evaluable patients with response was 7.9 months (range, 1.0–41.7) overall and 5.2 months (range, 3.0–13.9) in immunocompromised patients. No new safety signals were identified. The expanded access program closed for new requests on December 31, 2018, as required after regulatory approval; benefitting patients continued to receive avelumab.ConclusionsThe avelumab expanded access program for patients with mMCC demonstrated efficacy and safety in a real-world setting, consistent with the results from JAVELIN Merkel 200, and provided a treatment for patients with limited options

Adult T‐cell lymphoma in israeli patients of iranian origin

The clinical and laboratory features of four Israeli patients with adult T‐cell lymphoma‐leukemia (ATL) are presented. In three of them evidence for human T‐cell lymphotropic leukemia virus (HTLV‐I) infection was obtained. Interestingly, all of the patients immigrated to Israel from the same regions in Iran. Except for lack of skin involvement, the clinical course was typical for ATL as described worldwide. This is the first report of ATL in an Iranian cohort. This observation suggests that Iranian patients with ATL‐like illness should be studied for the presence of HTLV‐I infection

Stereotactic body radiotherapy for central lung tumors, yes we can!

Abstract Background SBRT is standard therapy for early stage lung cancer. Toxicity in central tumors has been a concern. RTOG 0813 showed that central SBRT is safe and effective. We report our experience with central SBRT. Methods We reviewed the records of patients treated with SBRT for central lung tumors (< 2 cm of the carina). Patients included primary lung cancer and recurrence following surgery and\ or conventional radiotherapy. All patients underwent 4DCT simulation and treatment planning was done with IMRT or VMAT techniques. Dose to the PTV was prescribed to the 95% isodose line. Results Seventy patients, between 5/09 and 4/13, were treated. Patients had early non-small cell lung cancer (n = 13) or locally recurrent lung cancer (n = 29) and pulmonary oligometastases (n = 28). Fifty-seven percent of the patients received BED of 132 with a schedule of 60Gy in 12 Gy fractions. Median follow up time was 18.3 months, 4/70 patients experienced local failure (6%). Median OS for the whole cohort was 4.6 years (CI 3-7 years). Ten patients had grade 1-2 radiation pneumonitis. One patient developed fatal bronchial bleeding. Conclusions SBRT for central tumors is safe and effective in patients with central disease, reiradiation, recurrence following surgery and in oligometastes