ArticleBMC cancer2025
Agnostic phase II, multicenter, single-arm study with DURVAlumab plus carboplatin or cisplatin and etoposide as first-line treatment in extensive stage - Extrapulmonary Small Cell Carcinoma (EPSCC) patients - DURVASCC trial (GOIRC-01-2021).
Article in BMC cancer, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06464068 (AGNOSTIC THERAPY IN A PHASE II, MULTICENTER, SINGLE-ARM STUDY IN FIRST-LINE TREATMENT OF DURVALUMAB IN ASSOCIATION WITH CARBOPLATIN OR CISPLATIN AND ETOPOSIDE IN PATIENTS AFFECTED BY EXTENSIVE STAGE - EXTRAPULMONARY SMALL CELL CARCINOMA), which is not on this map. Not yet cited in PubMed.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Agnostic therapy in a phase ii, multicenter, single-arm study in first-line treatment of durvalumab in association with carboplatin or cisplatin and etoposide in patients affected by extensive stage - extrapulmonary small cell carcinoma
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
19 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundEPSCCs represent rare and extremely aggressive tumors. In most cases, with widespread metastatic disease, the incidence rate is between 0.1% and 0.4%, and the median survival of less than one year. At present, chemotherapy is considered the only therapeutic strategy in the extensive stage of EPSCC. METHODS/
designThis is an open-label, multicenter, Italian phase II single-arm trial in which patients with extensive-stage EPSCC will receive first-line therapy with intravenously durvalumab (day 1) plus carboplatin or cisplatin, and etoposide (day 1-3) every 3 weeks for 4 or 6 cycles, as investigator's choice, followed by maintenance with durvalumab every 4 weeks for a maximum of 24 months. Durvalumab will be administered at a fixed dose of 1500 mg, cisplatin at 75 to 80 mg/m2 (day 1), carboplatin AUC 5-6 (day 1), and etoposide at 80-100 mg/m2 daily on days 1 to 3 every 3 weeks. The primary endpoint is the 12-month PFS. The study hypothesis is to detect an increase of at least 10% points compared to standard chemotherapy alone. Secondary endpoints include ORR, DoR, safety, and QoL. Collateral translational studies evaluate (i) whole-exome sequencing and gene expression profiling, and (ii) genetic alterations by circulating free DNA obtained from plasma samples. The trial is an ongoing enrollment; 21 of 66 planned patients have been enrolled. DISCUSSION: Considering the efficacy of immunotherapy plus chemotherapy in extensive SCLC and the low incidence of EPSCCs that limits the conduct of randomized trials, this therapeutic approach could be considered for the first time as an agnostic indication based on tumor histology, regardless of the tumor site. The DURVASCC study aims to demonstrate the role of anti-PDL1 antibody in combination with chemotherapy in first-line therapy of ES-EPSCC patients as a histology-related agnostic choice.
trial registrationClinicalTrials.gov: NCT06464068, June 18, 2024.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.