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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

Emiel De Jaeghere (UGent) , Sandra Tuyaerts, An M. T. Van Nuffel, Ann Belmans, Kris Bogaerts, Regina Baiden-Amissah, Lien Lippens (UGent) , Peter Vuylsteke, Stéphanie Henry, Xuan Bich Trinh, et al.
(2023) CANCER IMMUNOLOGY IMMUNOTHERAPY. 72(2). p.475-491
Author
Organization
Abstract
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).
Keywords
Cancer Research, Oncology, Immunology, Immunology and Allergy, Radioimmunotherapy, Drug therapy, combination, Gynecologic neoplasms, Immunomodulation, Tumor microenvironment, SOLID TUMORS, RADIATION-THERAPY, CANCER-PATIENTS, CELL CARCINOMA, CYCLOPHOSPHAMIDE, COMBINATION, CEMIPLIMAB, EFFICACY, SAFETY, CHEMOTHERAPY

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MLA
De Jaeghere, Emiel, et al. “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, vol. 72, no. 2, 2023, pp. 475–91, doi:10.1007/s00262-022-03253-x.
APA
De Jaeghere, E., Tuyaerts, S., Van Nuffel, A. M. T., Belmans, A., Bogaerts, K., Baiden-Amissah, R., … Denys, H. (2023). 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, 72(2), 475–491. https://doi.org/10.1007/s00262-022-03253-x
Chicago author-date
De Jaeghere, Emiel, Sandra Tuyaerts, An M. T. Van Nuffel, Ann Belmans, Kris Bogaerts, Regina Baiden-Amissah, Lien Lippens, et al. 2023. “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 72 (2): 475–91. https://doi.org/10.1007/s00262-022-03253-x.
Chicago author-date (all authors)
De Jaeghere, Emiel, Sandra Tuyaerts, An M. T. Van Nuffel, Ann Belmans, Kris Bogaerts, Regina Baiden-Amissah, Lien Lippens, Peter Vuylsteke, Stéphanie Henry, Xuan Bich Trinh, Peter A. van Dam, Sandrine Aspeslagh, Alex De Caluwé, Eline Naert, Diether Lambrechts, An Hendrix, Olivier De Wever, Koen Van de Vijver, Frédéric Amant, Katrien Vandecasteele, and Hannelore Denys. 2023. “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 72 (2): 475–491. doi:10.1007/s00262-022-03253-x.
Vancouver
1.
De Jaeghere E, Tuyaerts S, Van Nuffel AMT, Belmans A, Bogaerts K, Baiden-Amissah R, et al. 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. 2023;72(2):475–91.
IEEE
[1]
E. De Jaeghere et al., “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, vol. 72, no. 2, pp. 475–491, 2023.
@article{8764105,
  abstract     = {{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).}},
  author       = {{De Jaeghere, Emiel and Tuyaerts, Sandra and Van Nuffel, An M. T. and Belmans, Ann and Bogaerts, Kris and Baiden-Amissah, Regina and Lippens, Lien and Vuylsteke, Peter and Henry, Stéphanie and Trinh, Xuan Bich and van Dam, Peter A. and Aspeslagh, Sandrine and De Caluwé, Alex and Naert, Eline and Lambrechts, Diether and Hendrix, An and De Wever, Olivier and Van de Vijver, Koen and Amant, Frédéric and Vandecasteele, Katrien and Denys, Hannelore}},
  issn         = {{0340-7004}},
  journal      = {{CANCER IMMUNOLOGY IMMUNOTHERAPY}},
  keywords     = {{Cancer Research,Oncology,Immunology,Immunology and Allergy,Radioimmunotherapy,Drug therapy,combination,Gynecologic neoplasms,Immunomodulation,Tumor microenvironment,SOLID TUMORS,RADIATION-THERAPY,CANCER-PATIENTS,CELL CARCINOMA,CYCLOPHOSPHAMIDE,COMBINATION,CEMIPLIMAB,EFFICACY,SAFETY,CHEMOTHERAPY}},
  language     = {{eng}},
  number       = {{2}},
  pages        = {{475--491}},
  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}},
  url          = {{http://doi.org/10.1007/s00262-022-03253-x}},
  volume       = {{72}},
  year         = {{2023}},
}
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