Hemant Phatak

Systematic literature review of efficacy, safety and tolerability outcomes of chemotherapy regimens in patients with metastatic Merkel cell carcinoma

Aim: Merkel cell carcinoma (MCC) is a rare neuroendocrine, cutaneous malignancy with poor prognosis once metastasized. The aim of this study was to conduct a systematic literature review to assess clinical outcomes associated with chemotherapy regimens in metastatic MCC. >Materials & methods: Embase®, MEDLINE®, MEDLINE®-In-Process and CENTRAL were searched for studies published in January 2016. Results & conclusion: Overall, the literature on chemotherapy in patients with metastatic MCC is sparse, with most studies being case series/reports. Across all studies, response rates ranged from 20 to 61%, with higher response rates in first-line setting (53–61%) versus second-line setting (23–45%). Among responders, duration of response was short (≤8 months) in both first- and second-line settings. There is a need for novel agents that can induce durable responses in metastatic MCC.

Cost-effectiveness Analysis of Apixaban against Warfarin for Stroke Prevention in Patients with Nonvalvular Atrial Fibrillation in Japan

PURPOSEnThe aim of this study was to evaluate the cost-effectiveness of apixaban compared with to warfarin, current standard of care, for stroke prevention in patients with nonvalvular atrial fibrillation (NVAF) in Japan.nnnMETHODSnA previously published lifetime Markov model was adapted to evaluate the cost-effectiveness of apixaban compared with warfarin in patients with NVAF in Japan. In the same model, the costs associated with each clinical event and background mortality were replaced with Japanese data. Whenever available, some of the utility parameters were derived from Japanese published literature. Lifetime horizon was selected to evaluate the value of the treatment benefit (stroke prevention) against potential risks (such as major bleedings) among patients with NVAF. Direct medical cost, long-term care cost, and quality-adjusted life years (QALYs) were calculated from the payers perspective.nnnFINDINGSnCompared with warfarin, treatment with apixaban was estimated to increase life expectancy by 0.231 year or 0.240 QALYs while treatment cost increased by ¥511,692 (US

Using response evaluation criteria in solid tumors in real-world evidence cancer research

5117 at an exchange rate of US

Systematic literature review of efficacy, safety, and tolerability outcomes of interventions in patients with distant metastatic Merkel cell carcinoma.

1 = ¥100). The incremental cost-effectiveness ratio was ¥2,135,743 per QALY (US

Patient Characteristics And Treatment Patterns From Spear-Bladder: Study Informing Treatment Pathway Decision In Bladder Cancer

21,357 per QALY). On the basis of the results of the probabilistic sensitivity analysis, when the willingness-to-pay threshold was set at approximately ≥¥2,250,000 (US

Projecting Overall Survival (OS) With Immuno-Oncology (IO) Treatments: Application of Alternative Approaches in Metastatic Merkel Cell Carcinoma (MMCC)

22,500) per QALY, the probability of apixaban being cost-effective was ≥50%. Assuming a willingness-to-pay threshold of ¥5,000,000 (US

SPEAR-bladder (study informing treatment pathway decision in bladder cancer): First- through third-line time to treatment failure in the US.

50,000) and ¥6,700,000 (US

Projecting long term survival for avelumab in refractory Merkel cell carcinoma.

67,000) in Japan, the probability of apixaban being cost-effective was 85% and 91%, respectively.nnnCONCLUSIONnAlthough most participants in the Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation (ARISTOTLE) trial used for the efficacy data of apixaban in the model were non-Japanese patients, the impact of the limitations on our results was considered small, and our results were deemed robust because of the additional effect in Japanese patients compared with that in the global population according to the subanalysis of Japanese patients in the trial. Therefore, based on an adaptation of a published Markov model, apixaban is a cost-effective alternative to warfarin in Japan for stroke prevention among patients with NVAF.

Budget Impact Analysis of Avelumab in Patients with Metastatic Merkel Cell Carcinoma in The US

AIMnReal-world evidence of charted treatment responses to cancer drug therapy was compared with medical record derived radiographic measurements of target lesions per Response Evaluation Criteria in Solid Tumors (RECIST).nnnMATERIALS & METHODSn15 physicians treating 59 metastatic Merkel cell cancer (mMCC) patients contributed patient-level data. A comparison of medical record reported best response with radiographic measurements per RECIST of pre- and post-treatment target lesions.nnnRESULTSnRECIST response rates were significantly lower compared with medical record reported with a concordance of 43.2% (95%xa0CI: 28.0-58.4%).nnnCONCLUSIONnSubjective assessment of tumor response collected via traditional chart abstraction may overestimate benefit and limit the potential role of real-world evidence in value-based care research. The use of target lesion measurements presents an attractive alternative that better aligns with trial results.