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Title:
Pembrolizumab, radiotherapy, and an immunomodulatory five-drug cocktail in pretreated patients with persistent, recurrent, or metastatic cervical or endometrial carcinoma: Results of the phase II PRIMMO study | Cancer Immunology, Immunotherapy
Description:
A phase II study (PRIMMO) of patients with pretreated persistent/recurrent/metastatic cervical or endometrial cancer is presented. Patients received an immunomodulatory five-drug cocktail (IDC) consisting of low-dose cyclophosphamide, aspirin, lansoprazole, vitamin D, and curcumin starting 2 weeks before radioimmunotherapy. Pembrolizumab was administered three-weekly from day 15 onwards; one of the tumor lesions was irradiated (8Gyx3) on days 15, 17, and 19. The primary endpoint was the objective response rate per immune-related response criteria (irORR) at week 26 (a lower bound of the 90% confidence interval [CI] of > 10% was considered efficacious). The prespecified 43 patients (cervical, n = 18; endometrial, n = 25) were enrolled. The irORR was 11.1% (90% CI 2.0–31.0) in cervical cancer and 12.0% (90% CI 3.4–28.2) in endometrial cancer. Median duration of response was not reached in both cohorts. Median interval-censored progression-free survival was 4.1 weeks (95% CI 4.1–25.7) in cervical cancer and 3.6 weeks (95% CI 3.6–15.4) in endometrial cancer; median overall survival was 39.6 weeks (95% CI 15.0–67.0) and 37.4 weeks (95% CI 19.0–50.3), respectively. Grade ≥ 3 treatment-related adverse events were reported in 10 (55.6%) cervical cancer patients and 9 (36.0%) endometrial cancer patients. Health-related quality of life was generally stable over time. Responders had a significantly higher proportion of peripheral T cells when compared to nonresponders (p = 0.013). In conclusion, PRIMMO did not meet its primary objective in both cohorts; pembrolizumab, radiotherapy, and an IDC had modest but durable antitumor activity with acceptable but not negligible toxicity. Trial registration ClinicalTrials.gov (identifier NCT03192059) and EudraCT Registry (number 2016-001569-97).
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Keywords {🔍}
patients, response, cancer, study, article, cervical, cohort, google, scholar, pubmed, endometrial, tumor, pembrolizumab, treatment, radiotherapy, cells, cas, criteria, data, table, belgium, weeks, week, clinical, tumors, disease, analysis, safety, oncol, phase, recist, grade, supplemental, oncology, personal, full, cohorts, reported, immune, results, van, ici, cell, version, carcinoma, adverse, sbrt, solid, patient, idc,
Topics {✒️}
persistent/recurrent/metastatic microsatellite instability-high stromal tumor-infiltrating lymphocytes cd45+cd3+cd4+cd8−cd25highcd127lowfoxp3+ assessing tumor-infiltrating lymphocytes functional/exhausted tumor-specific cd8 systemic inflammatory markers interval-censored progression-free survival regina baiden-amissah enhance t-cell activation single-agent anti–pd single-agent anti-pd-1 response bar + case id + location response bar + characteristics + swimmer lane de olza mo specific t-cell type regulatory t-cell modulation article download pdf cd45+cd3+cd4+cd8− cd45+cd3+cd4−cd8+ pretreated persistent/recurrent/metastatic cervical small-cell lung cancer katrien vandecasteele & hannelore persistent/recurrent/metastatic cc patients mismatch repair-deficient esgo/estro/esp guidelines immune-related response criteria specific molecular profile node-positive cervical cancer /wilcoxon rank-sum test general hospital sint-maarten persistent/recurrent/metastatic cc alex de caluw� t-cell migration brien-fleming stopping boundaries persistent/recurrent/metastatic cervical increased ici-induced cytotoxicity xuan bich trinh pd-1/pd-l1 axis short-term induction period health-related quality treatment-related adverse events median progression-free survival observed toxicity profile absolute lymphocyte count interval-censored irpfs biomarker profiles radiation-induced cxcl16 release immunosuppressive tumor microenvironment remain receiving treatment prior systemic therapy
Questions {❓}
- Demaria S, Guha C, Schoenfeld J, Morris Z, Monjazeb A, Sikora A et al (2021) Radiation dose and fraction in immunotherapy: one-size regimen does not fit all settings, so how does one choose?
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headline:Pembrolizumab, radiotherapy, and an immunomodulatory five-drug cocktail in pretreated patients with persistent, recurrent, or metastatic cervical or endometrial carcinoma: Results of the phase II PRIMMO study
description:A phase II study (PRIMMO) of patients with pretreated persistent/recurrent/metastatic cervical or endometrial cancer is presented. Patients received an immunomodulatory five-drug cocktail (IDC) consisting of low-dose cyclophosphamide, aspirin, lansoprazole, vitamin D, and curcumin starting 2 weeks before radioimmunotherapy. Pembrolizumab was administered three-weekly from day 15 onwards; one of the tumor lesions was irradiated (8Gyx3) on days 15, 17, and 19. The primary endpoint was the objective response rate per immune-related response criteria (irORR) at week 26 (a lower bound of the 90% confidence interval [CI] of > 10% was considered efficacious). The prespecified 43 patients (cervical, n = 18; endometrial, n = 25) were enrolled. The irORR was 11.1% (90% CI 2.0–31.0) in cervical cancer and 12.0% (90% CI 3.4–28.2) in endometrial cancer. Median duration of response was not reached in both cohorts. Median interval-censored progression-free survival was 4.1 weeks (95% CI 4.1–25.7) in cervical cancer and 3.6 weeks (95% CI 3.6–15.4) in endometrial cancer; median overall survival was 39.6 weeks (95% CI 15.0–67.0) and 37.4 weeks (95% CI 19.0–50.3), respectively. Grade ≥ 3 treatment-related adverse events were reported in 10 (55.6%) cervical cancer patients and 9 (36.0%) endometrial cancer patients. Health-related quality of life was generally stable over time. Responders had a significantly higher proportion of peripheral T cells when compared to nonresponders (p = 0.013). In conclusion, PRIMMO did not meet its primary objective in both cohorts; pembrolizumab, radiotherapy, and an IDC had modest but durable antitumor activity with acceptable but not negligible toxicity. Trial registration ClinicalTrials.gov (identifier NCT03192059) and EudraCT Registry (number 2016-001569-97).
datePublished:2022-08-12T00:00:00Z
dateModified:2024-12-30T00:00:00Z
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Radioimmunotherapy
Drug therapy, combination
Gynecologic neoplasms
Immunomodulation
Tumor microenvironment
Oncology
Immunology
Cancer Research
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headline:Pembrolizumab, radiotherapy, and an immunomodulatory five-drug cocktail in pretreated patients with persistent, recurrent, or metastatic cervical or endometrial carcinoma: Results of the phase II PRIMMO study
description:A phase II study (PRIMMO) of patients with pretreated persistent/recurrent/metastatic cervical or endometrial cancer is presented. Patients received an immunomodulatory five-drug cocktail (IDC) consisting of low-dose cyclophosphamide, aspirin, lansoprazole, vitamin D, and curcumin starting 2 weeks before radioimmunotherapy. Pembrolizumab was administered three-weekly from day 15 onwards; one of the tumor lesions was irradiated (8Gyx3) on days 15, 17, and 19. The primary endpoint was the objective response rate per immune-related response criteria (irORR) at week 26 (a lower bound of the 90% confidence interval [CI] of > 10% was considered efficacious). The prespecified 43 patients (cervical, n = 18; endometrial, n = 25) were enrolled. The irORR was 11.1% (90% CI 2.0–31.0) in cervical cancer and 12.0% (90% CI 3.4–28.2) in endometrial cancer. Median duration of response was not reached in both cohorts. Median interval-censored progression-free survival was 4.1 weeks (95% CI 4.1–25.7) in cervical cancer and 3.6 weeks (95% CI 3.6–15.4) in endometrial cancer; median overall survival was 39.6 weeks (95% CI 15.0–67.0) and 37.4 weeks (95% CI 19.0–50.3), respectively. Grade ≥ 3 treatment-related adverse events were reported in 10 (55.6%) cervical cancer patients and 9 (36.0%) endometrial cancer patients. Health-related quality of life was generally stable over time. Responders had a significantly higher proportion of peripheral T cells when compared to nonresponders (p = 0.013). In conclusion, PRIMMO did not meet its primary objective in both cohorts; pembrolizumab, radiotherapy, and an IDC had modest but durable antitumor activity with acceptable but not negligible toxicity. Trial registration ClinicalTrials.gov (identifier NCT03192059) and EudraCT Registry (number 2016-001569-97).
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dateModified:2024-12-30T00:00:00Z
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pageEnd:491
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keywords:
Radioimmunotherapy
Drug therapy, combination
Gynecologic neoplasms
Immunomodulation
Tumor microenvironment
Oncology
Immunology
Cancer Research
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