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Curative-Intent Treatment with Durvalumab in Early-Stage Cancers.

ABSTRACT: The introduction of immunotherapy has fundamentally transformed the treatment landscape in cancer, providing long-term survival benefit for patients with advanced disease across multiple tumor types, including non-small cell lung cancer (NSCLC). In the placebo-controlled phase 3 PACIFIC trial, the PD-L1 inhibitor durvalumab demonstrated significant improvements in progression-free survival and overall survival in patients with unresectable, stage III NSCLC who had not progressed after platinum-based chemoradiotherapy (CRT). These findings have led to the widespread acceptance of the 'PACIFIC regimen' (durvalumab after CRT) as the standard of care in this setting. Moreover, the PACIFIC trial is the first study to demonstrate a proven survival advantage with an immunotherapy in a curative-intent setting, thereby providing a strong rationale for further investigation of durvalumab in early-stage cancers. Herein, we describe the extensive clinical development program for durvalumab across multiple tumor types in curative-intent settings, outlining the scientific rationale(s) for its use and highlighting the innovative research (e.g., personalized cancer monitoring) advanced by these trials.

SUBMITTER: Melillo G

PROVIDER: S-EPMC8190020 | biostudies-literature | 2021 Jun

REPOSITORIES: biostudies-literature

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Curative-Intent Treatment with Durvalumab in Early-Stage Cancers.

Melillo Giovanni G Chand Vikram V Yovine Alejandro A Gupta Ashok A Massacesi Cristian C

Advances in therapy 20210421 6

The introduction of immunotherapy has fundamentally transformed the treatment landscape in cancer, providing long-term survival benefit for patients with advanced disease across multiple tumor types, including non-small cell lung cancer (NSCLC). In the placebo-controlled phase 3 PACIFIC trial, the PD-L1 inhibitor durvalumab demonstrated significant improvements in progression-free survival and overall survival in patients with unresectable, stage III NSCLC who had not progressed after platinum-b ...[more]

PMID: 33881745

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Project description:ImportanceFollow-up assessment of patients who had treatment for head and neck cancer is critical and an important part of the overall treatment program. During each visit to the hospital, patients are evaluated by a physician and may undergo additional tests. Because it has been observed that the symptoms mentioned by patients often guide the treating clinicians in identifying cancer recurrence, an appropriately constructed questionnaire can help clinicians determine which patients need further testing as a result of a recurrence and which patients can continue to be monitored remotely.ObjectiveTo evaluate the role of a symptom-based telephone questionnaire in detecting recurrences in patients with radically treated oral cancer.Design, setting, and participantsThis prospective diagnostic cohort study was conducted from October 1, 2018, to February 28, 2019. This study took place at Tata Memorial Centre, an apex referral cancer center in India. A total of 615 consecutive patients with oral cancer were screened, of whom 400 patients consented to be a part of the study. After completion of curative treatment, these patients were followed up for 2 months to 2 years. We excluded patients younger than 18 years or older than 80 years, those with Eastern Cooperative Oncology Group status greater than 2, and those who had already been diagnosed with recurrent disease.Interventions/exposuresThe patients were contacted 2 weeks before their clinic appointment, and a telephone interview was conducted using a predefined questionnaire. Based on patients' responses to these questions, their disease status was estimated. Subsequently, during the actual follow-up visit, a trained head and neck surgeon, who was blinded to the questionnaire result, examined them.Main outcomes and measuresThe sensitivity and specificity of the telephone questionnaire were calculated by comparing its results with those of the trained head and neck surgeon after the clinical evaluation.ResultsOf the 615 patients screened, 400 consented to be part of the study. Participants had a median (interquartile range) age of 49 (41-56) years, and 334 (83.5%) were men. Recurrence was noted in 20 patients (5.0%). The telephone-based questionnaire was found to have sensitivity of 90.0%, specificity of 74.2%, positive predictive value of 15.5%, and negative predictive value of 99.3%. Clinical examination values were 100.0%, 92.9%, 42.5%, and 100.0%, respectively. A total of 124 patients (31.0%) said that they would prefer such a telephone follow-up compared with an actual physical follow-up visit.Conclusions and relevanceThis diagnostic cohort study found that a symptom-based telephone questionnaire had good sensitivity and negative predictive value for detecting recurrences in patients with oral cancer on follow-up evaluation after completion of definitive treatment.

Project description:ObjectivesThe aim of this study is to examine caregiver burden of spousal caregivers of patients with esophageal cancer after curative treatment with neoadjuvant chemoradiation followed by resection and to assess factors associated with caregiver burden.MethodsIn this exploratory, cross-sectional study, spousal caregivers and patients were eligible if the caregiver was the patient's spouse and the patient had been treated with chemoradiation followed by surgery after esophageal carcinoma diagnosis. Forty-seven couples were included. Spousal caregivers completed a questionnaire, examining caregivers' burden (Self-Perceived Pressure from Informal Care (SPPIC, Dutch)), caregiver unmet needs (SCNS-P&S), anxiety and depression (Hospital Anxiety and Depression Scale (HADS)), and marital satisfaction (Maudsley Marital Questionnaire (MMQ)). Patients completed the latter two questionnaires and a cancer specific quality of life questionnaire (EORTC-QLQ C30 and OES18 (oesophageal module). Logistic regression analysis was performed to identify correlates for caregiver burden.ResultsThe median time after esophagectomy was 38 months. Thirty-four percent of the spousal caregivers reported moderate or high burden. Spousal caregivers most frequently reported unmet needs were managing concerns about the cancer coming back (43%), dealing with others not acknowledging the impact on your life of caring for a person with cancer (38%), and balancing the needs of the person with cancer and one's own needs. A comparable proportion of spousal caregivers and patients showed symptoms of anxiety (23 vs 17%) and depression (17 vs 17%). Spousal caregivers reported significantly more dissatisfaction than patients on the marital scale (p < 0.01). Factors independently associated with higher caregiver burden were fatigue of the patient (OR = 1.66, 95% CI 1.12-2.47) and depression of the spousal caregiver (OR = 1.44, 95% CI 1.11-1.86).ConclusionsMore than a third of the spousal caregivers of patients with esophageal cancer treated with curative intent report moderate or high burden 3 years after treatment. Fatigue of the patient and depression of the spousal caregiver are associated with caregiver burden. To improve clinical care, identification of spousal caregivers at risk for experiencing higher caregiver burden and implementation of specific interventions is needed.

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Curative-Intent Treatment with Durvalumab in Early-Stage Cancers.

Publications

Curative-Intent Treatment with Durvalumab in Early-Stage Cancers.

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