臨床研究等提出・公開システム

A multicenter, open-label, prospective study of durvalumab, etoposide, and carboplatin for unresectable small cell lung cancer with mild idiopathic interstitial pneumonia (DREAM study)

DREAM study (DREAM study)

22

The patients median age was 74 years. Most patients had stage IV disease (90%) and an ECOG PS of 1 (67%). The median %VC was 96% (range: 81-118%). 13 patients displayed a probable UIP pattern while 8 patients had an indeterminate for UIP pattern. Three patients had chronic obstructive pulmonary disease. Median follow-up was 8.6 months (range 1.1-28.2).

Between January 2021 and February 2023, informed consent was obtained from 25 patients. However, 3 patients did not meet the eligibility criteria. As a result, 22 patients were enrolled. However, one patient did not start study treatment. Therefore, 21 patients who received at least one study treatment were included in the analysis population.

Safety analysis included all 21 patients. 19 treatment-related grade 3/4 hematologic events in induction phase; 17 events of neutrophil decrease and 2 events of platelet count decrease. Three treatment-related grade 3/4 non-hematologic events in induction phase; 1 event of pneumonitis, 1 event of AST increased and 1 event of hyponatremia. There was just one event of pneumonitis as treatment-related death. Two patients developed toxicity leading to the discontinuation of durvalumab plus etoposide and carboplatin therapy (both cases had pneumonitis).

Two patients (9.5%) had any grade pneumonitis during the induction phase; one patient with Grade 1, and one patient with Grade 5. The severe-pneumonitis free rate was 95.2% (95% confidence interval 77.3-99.2%) (20/21 patients). The overall response rate was 90%; one patient achieved CR and 18 achieved PR. Furthermore, 9.5% of patients had SD.

The combination therapy of durvalumab, etoposide, and carboplatin as first line treatment for patients with ES-SCLC complicated with mild IIP can be a feasible treatment approach.

Mar. 01, 2025

Sept. 19, 2024

https://www.sciencedirect.com/science/article/pii/S0169500224004926?via%3Dihub

No

None

https://jrct.mhlw.go.jp/latest-detail/jRCTs051200109

Fujimoto Daichi

Wakayama Medical University Hospital

811-1 Kimiidera, Wakayama-shi, Wakayama, Japan

daichi@wakayama-med.ac.jp

Shibaki Ryota

Wakayama Medical University Hospital

811-1 Kimiidera,Wakayama-shi,Wakayama, Japan

+81-73-441-0619

shibaki@wakayama-med.ac.jp

Complete

Jan. 15, 2021

Interventional

single arm study

open(masking not used)

historical control

single assignment

treatment purpose

Key inclusion criteria are as follows: 1) patients who have unresectable extensive disease, 2) patients whose tumor is histologically or cytologically confirmed small cell lung cancer, 3) patients aged >=20 years, 4) patients with Eastern Cooperative Oncology Group performance status of 0 to 1, 5) patients have no previous chemotherapy or immune checkpoint inhibitor for small cell lung cancer, 6) patients with chronic fibrotic IP, 7) patients diagnosed as Probable UIP pattern, Indeterminate for UIP pattern, and Alternative diagnosis pattern according to the ATS/ERS/JRS/LATS association official guidelines, and 8) patients with adequate organ function.

Key exclusion criteria are as follows: 1) any history of previous malignancy in the past 5 years, 2) any history of autoimmune disease (patients who have controlled thyroid dysfunction or skin disease that does not require systemic therapy eligible), 3) %VC <80%, 4) patients diagnosed as definite UIP pattern, 5) other interstitial lung disease including connective tissue disease-ILD, pneumoconiosis, and drug-induced pneumonitis, 6) history of taking corticosteroid, other immunosuppressive drug, pirfenidone, and nintedanib within 14 days before registration, and 7) patients with symptomatic brain metastasis or meningeal carcinomatosis.

Both

Small cell lung cancer

Patients will receive etoposide (<75 years old: 100mg/m2; >=75 years old: 80mg/m2; intravenously on day 1-3), carboplatin (area under the curve 5 mg/mL intravenously on day 1), and durvalumab (1500mg/body intravenously on day1) every three weeks for four cycles. Thereafter, patients will continue to receive durvalumab monotherapy (1500mg/body intravenously on day 1 every three weeks), until relapse, or unacceptable toxicity.

Severe_pneumonitis-free rate

progression-free survival, overall survival, time to treatment failure, time to pneumonitis, and rate of adverse events

+81-73-441-0896

Oct. 27, 2020

none