A randomized phase III study comparing continuation and discontinuation of PD-1 pathway inhibitors for patients with advanced non-small-cell lung cancer (JCOG1701, SAVE study)

Nomura, Shosaku; Goto, Yasushi; Kataoka, Tomoko; Kawai, Shoko; Okuma, Yusuke; Murakami, Haruyasu; Tanaka, Kentaro; Ohe, Yuichiro

doi:10.1093/jjco/hyaa054

Cited by 24 publications

(15 citation statements)

References 19 publications

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“…Clinical trials are currently underway in Japan. 20 In conclusion, in this study, we present a case of an elderly patient showing CR of NSCLC following treatment with pembrolizumab. The CR was maintained for one and a half years after discontinuation of two years of treatment.…”

Section: Discussionmentioning

confidence: 79%

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Complete response of squamous cell carcinoma of the lung following treatment with pembrolizumab in an elderly patient: A case report

et al. 2020

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Complete response of non-small cell lung cancer (NSCLC) with immune checkpoint inhibitor (ICI) monotherapy is rare. Here, we encountered an elderly patient who showed complete response of NSCLC following treatment with pembrolizumab. An 84-year-old man with a history of bloody sputum for several weeks visited a general physician. At that time, a chest X-ray revealed a tumor shadow in the left middle lung field, and the patient was referred to our hospital. Following transbronchial biopsy, he was diagnosed with squamous cell carcinoma of the lung. Expression of programmed death ligand 1 (PD-L1) in tumor cells was 80% or more by immunostaining. Based on the above, immunotherapy with pembrolizumab was performed as first-line therapy. The cancer cells completely disappeared at the end of the fifth cycle. There were no side effects during the therapeutic course. Treatment with pembrolizumab continued for two years and was then discontinued at the patient's request. Since then, no tumor recurrence has been detected for about one and a half years without treatment. There have been few reports of lung cancer disappearing after treatment with pembrolizumab. In conclusion, in elderly NSCLC patients with PD-L1 expression of 50% or more, pembrolizumab should be considered as first-line treatment with the treatment period, and mechanism suggested in this report.

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Section: Discussionmentioning

confidence: 79%

“…If the tumor completely disappears as in the present case, then it may be possible to administer pembrolizumab for a certain period, discontinue it, and if cancer recurs, re‐challenge it. Clinical trials are currently underway in Japan 20 …”

Section: Discussionmentioning

confidence: 99%

Complete response of squamous cell carcinoma of the lung following treatment with pembrolizumab in an elderly patient: A case report

et al. 2020

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“…A number of clinical trials focusing on ICIs discontinuation are carrying out. Similar to CheckMate 153, the Japanese phase III SAVE study ( 130 )recruits NSCLCs with good response and no serious side effects after 1-year anti-PD-1/L1 therapy, the French DICIPLE study ( 131 ) recruits patients with stage IV NSCLC without progression after 6-months combination therapy of nivolumab plus ipilimumab, and the UK phase III DANTE study ( 132 ) recruits progression-free melanomas after 1-year anti-PD-1 therapy. The patients were randomized into the continuation and discontinuation groups to compare the survival differences.…”

Section: Ongoing Clinical Trials Related To Icis Regimen Optimizationmentioning

confidence: 99%

Dosing Regimens of Immune Checkpoint Inhibitors: Attempts at Lower Dose, Less Frequency, Shorter Course

Jiang

Liu

et al. 2022

Front. Oncol.

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Immune checkpoint inhibitors (ICIs) are a revolutionary breakthrough in the field of cancer by modulating patient’s own immune system to exert anti-tumor effects. The clinical application of ICIs is still in its infancy, and their dosing regimens need to be continuously adjusted. Pharmacokinetic/pharmacodynamic studies showed a significant plateau in the exposure-response curve, with high receptor occupancy and plasma concentrations achieved at low dose levels. Coupled with concerns about drug toxicity and heavy economic costs, there has been an ongoing quest to reevaluate the current ICI dosing regimens while preserving maximum clinical efficacy. Many clinical data showed remarkable anticancer effects with ICIs at the doses far below the approved regimens, indicating the possibility of dose reduction. Our review attempts to summarize the clinical evidence for ICIs regimens with lower-dose, less-frequency, shorter-course, and provide clues for further ICIs regimen optimization.

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“…[49][50][51][52][53][54] Furthermore, because many patients treated with immune checkpoint inhibitors have prolonged progression-free survival (PFS) despite treatment discontinuation (e.g., due to adverse events), [55][56][57][58][59][60] the optimal duration of treatment is unknown. [61][62][63] Strategy to Identify Candidate Drugs for Financially Guided Dosing…”

Section: Overviewmentioning

confidence: 99%

The Right Dose: From Phase I to Clinical Practice

Groenland

Ratain

Chen

et al. 2021

American Society of Clinical Oncology Educational Book

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To realize the full potential of promising new anticancer drugs, it is of paramount importance to administer them at the right dose. The aim of this educational article is to provide several opportunities to optimize anticancer drug dosing, focusing on oral targeted therapies. First, therapeutic drug monitoring can optimize exposure in individual patients, if the optimal concentration is known. This approach is of particular interest in regard to oral kinase inhibitors with high interindividual pharmacokinetic variability. If exposure is related to response, then therapeutic drug monitoring is potentially feasible, although the clinical utility of this approach has not yet been established. Other approaches to reduce variability include administration of more frequent, smaller doses and administration under optimal prandial conditions. However, for many drugs, the labeled dose has not been demonstrated to be the optimal dose; for such agents, the vast majority of patients may be receiving excessive doses, which results in excessive toxicity. Furthermore, administration of lower off-label doses may reduce both medical and financial toxicity. These strategies should be applied from registration studies to clinical practice, with the goal of better optimizing anticancer treatment.

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A randomized phase III study comparing continuation and discontinuation of PD-1 pathway inhibitors for patients with advanced non-small-cell lung cancer (JCOG1701, SAVE study)

Cited by 24 publications

References 19 publications

Complete response of squamous cell carcinoma of the lung following treatment with pembrolizumab in an elderly patient: A case report

Complete response of squamous cell carcinoma of the lung following treatment with pembrolizumab in an elderly patient: A case report

Dosing Regimens of Immune Checkpoint Inhibitors: Attempts at Lower Dose, Less Frequency, Shorter Course

The Right Dose: From Phase I to Clinical Practice

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