– Utah778/Iistock – Archive
MADRID 1 Dic. (EUROPA PRESS) –
The pharmaceutical company AstraZeneca has reported that durvalumab has shown a manageable safety profile and promising results in patients with extended-stage small cell lung cancer (SCLC), according to the final data from the phase IIIB CANTABRICO trial, carried out in 31 Spanish hospitals.
The study, which included 101 patients treated with durvalumab in combination with platinum-etoposide in the first line, is a multicenter, single-arm trial, which aimed to evaluate the safety, effectiveness and quality of life, of the first-line treatment with the drug durvalumab, in combination with platinum-etoposide, of a population of extended-stage CPM patients close to real life in Spain.
Extended-stage small cell lung cancer is traditionally associated with a poor prognosis, with a 5-year overall survival (OS) rate (<5%) with traditional chemotherapy treatment. Based on the results of studies such as CASPIAN9, standard treatment with carboplatin and etoposide plus immunotherapy followed by maintenance immunotherapy is currently recommended as first-line treatment for these patients.
“Immunotherapy trials involving patients with extended or advanced stage small cell lung cancer (with metastasis) were needed in real clinical practice, which is why CANTÁBRICO emerged,” says Dr. Dolores Isla, president of the Association for Research on Lung Cancer in Women (ICAPEM), head of the Medical Oncology Service at the Lozano Blesa University Hospital in Zaragoza, and researcher of the trial.
According to him, “this phase IIIB trial suggests that first-line treatment of patients with extended-stage small cell lung cancer could be feasible with an initial regimen of up to six cycles with the drug plus platinum-etoposide followed by maintenance with the drug, potentially providing more options in daily clinical practice for the management of these patients based on their characteristics.”
The efficacy results were consistent with those expected from previous studies in this setting, such as CASPIAN. Thus, the median PFS in the CASPIAN study in the last update was 5.4 months, and the PFS rate was 45.4% at 6 months and 17.9% at 12 months. However, in this study, the median PFS was 6.1 months and the PFS rates were 53.0% and 21.0% at 6 and 12 months, respectively.
In the CASPIAN study, the median OS was 12.9 months and the 18-month survival rate was 32%. In CANTABRICO, the corresponding figures were 9.6 months and 31.6%, respectively.
“The CANTABRICO study showed that this first-line treatment with up to six cycles of induction therapy had a manageable toxicity profile,” highlights Dr. Luis Paz-Ares, head of the Medical Oncology Service at the 12 de Octubre University Hospital in Madrid and researcher of the trial, who highlights that, “to date, there are still 6 patients who continue on treatment after more than 4 years.”
DEVELOPMENT OF THE STUDY
The trial was carried out in 31 centers in Spain, between December 2020 and June 2023, with 101 adult patients. The median age was 65 years (56% were = 65 years). The majority of patients were men (n = 68; 67.3%) and the majority had stage IV disease (n = 87; 86.1%). Six patients (5.9%) had an ECOG of 2, eleven (10.9%) had brain metastases, ten (9.9%) had progressed from previously limited disease, and thirty-three (32.7%) had liver metastases.
Patients received the drug plus platinum-etoposide for up to 6 cycles, followed by the drug alone every 4 weeks as a single agent. Primary outcomes included the incidence of EQUAL grade 3 adverse events (AEs) and immune-mediated AEs (imAEs). Grade 3 or higher AEs occurred in 77 patients (76.2%) and were considered treatment-related in 58 patients (57.4%).
Thirty-eight patients (37.6%) reported at least one imAE, all of which were considered treatment-related. Among the 82 imADs reported during the study, 68 (82.9%) were grade 1-2. The median overall survival (OS) was 9.6 months (95% CI, 7.8 to 11.3), and the 12- and 24-month OS ratios were 40.7% (31.1% to 50.3%) and 25.4% (95% CI, 16.8% to 34.0%), respectively.
“This study not only represents a scientific advance, but also a particularly emotional achievement for AstraZeneca and for all of us who have been part of the project: CANTABRICO was the company’s first local trial after more than a decade, becoming an initiative highly appreciated by both our team and the participating oncologists,” says Laura Colon, Director of Oncology at AstraZeneca in Spain.
