Treatment of advanced BP-NETS with lanreotide autogel/depot vs placebo: The phase III SPINET study Journal Article
| Authors: | Baudin, E.; Capdevila, J.; Hörsch, D.; Singh, S.; Caplin, M. E.; Wolin, E. M.; Buikhuisen, W.; Raderer, M.; Dansin, E.; Grohe, C.; Ferone, D.; Houchard, A.; Truong-Thanh, X. M.; Reidy-Lagunes, D.; on behalf of the SPINET Study Group |
| Article Title: | Treatment of advanced BP-NETS with lanreotide autogel/depot vs placebo: The phase III SPINET study |
| Abstract: | Prospective data are lacking on early somatostatin analog (SSA) therapy in bronchopulmonary neuroendocrine tumors (BP-NETs; typical carcinoids and atypical carcinoids (TCs and ACs)). SPINET (EudraCT: 2015-004992-62; NCT02683941) was a phase III, double-blind study of lanreotide autogel/depot (LAN; 120 mg every 28 days) plus best supportive care (BSC) vs placebo plus BSC, with an optional open-label treatment phase (LAN plus BSC). Patients had metastatic/unresectable, somatostatin receptor (SSTR)-positive TCs or ACs. Recruitment was stopped early owing to slow accrual; eligible patients from the double-blind phase transitioned to open-label LAN. The adapted primary endpoint was progression-free survival (PFS) during either phase for patients receiving LAN. Seventy-seven patients were randomized (LAN, n = 51 (TCs, n = 29; ACs, n = 22); placebo, n = 26 (TCs, n = 16; ACs, n = 10)). Median (95% CI) PFS during double-blind and open-label phases in patients receiving LAN was 16.6 (11.3; 21.9) months overall (primary endpoint), 21.9 (12.8, not calculable (NC)) months in TCs, and 13.8 (5.4; 16.6) months in ACs. During double-blind treatment, median (95% CI) PFS was 16.6 (11.3; 21.9) months for LAN vs 13.6 (8.3; NC) months for placebo (not significant); corresponding values were 21.9 (13.8; NC) and 13.9 (13.4; NC) months, respectively, in TCs and 13.8 (5.4; 16.6) and 11.0 (2.8; 16.9) months, respectively, in ACs. Patients’ quality of life did not deteriorate and LAN was well tolerated. Although recruitment stopped early and the predefined sample size was not met, SPINET is the largest prospective study to date of SSA therapy in SSTR-positive TCs and ACs and suggests clinical benefit in TCs. © 2024 the author(s) |
| Keywords: | adult; cancer survival; controlled study; aged; aged, 80 and over; middle aged; cancer surgery; treatment failure; major clinical study; clinical trial; fatigue; cisplatin; diarrhea; drug efficacy; systemic therapy; antineoplastic agents; capecitabine; paclitaxel; cancer radiotherapy; temozolomide; positron emission tomography; antineoplastic agent; prospective study; biological marker; protein blood level; carboplatin; metastasis; progression free survival; quality of life; etoposide; randomized controlled trial; lung neoplasms; vincristine; food and drug administration; abdominal pain; neuroendocrine tumor; lung tumor; multicenter study; open study; octreotide; phase 3 clinical trial; inoperable cancer; drug therapy; double blind procedure; double-blind method; flatulence; chromogranin; pemetrexed; everolimus; angiopeptin; peptides, cyclic; cyclopeptide; somatostatin derivative; somatostatin; neuroendocrine tumors; bronchus carcinoid; pentetreotide; somatostatin receptor; 5 hydroxyindoleacetic acid; atypical carcinoid; typical carcinoid; somatostatin analog; upper abdominal pain; response evaluation criteria in solid tumors; licence; time to treatment; very elderly; humans; human; male; female; article; vinorelbine tartrate; ecog performance status; european organization for research and treatment of cancer quality of life questionnaire core 30; bronchopulmonary neuroendocrine tumors |
| Journal Title: | Endocrine-Related Cancer |
| Volume: | 31 |
| Issue: | 9 |
| ISSN: | 1351-0088 |
| Publisher: | Bioscientifica Ltd |
| Date Published: | 2024-09-01 |
| Start Page: | e230337 |
| Language: | English |
| DOI: | 10.1530/erc-23-0337 |
| PUBMED: | 38913539 |
| PROVIDER: | scopus |
| PMCID: | PMC11301421 |
| DOI/URL: | |
| Notes: | Article -- Source: Scopus |
