التفاصيل البيبلوغرافية
العنوان: |
177 Lu-DOTATATE Efficacy and Safety in Functioning Neuroendocrine Tumors: A Joint Analysis of Phase II Prospective Clinical Trials. |
المؤلفون: |
Bongiovanni, Alberto, Nicolini, Silvia, Ibrahim, Toni, Foca, Flavia, Sansovini, Maddalena, Di Paolo, Arianna, Grassi, Ilaria, Liverani, Chiara, Calabrese, Chiara, Ranallo, Nicoletta, Matteucci, Federica, Paganelli, Giovanni, Severi, Stefano |
المصدر: |
Cancers; 12/15/2022, Vol. 14 Issue 24, p6022, 12p |
مصطلحات موضوعية: |
DISEASE progression, CLINICAL trials, DRUG tolerance, METASTASIS, OCTREOTIDE acetate, ORGANOMETALLIC compounds, TREATMENT effectiveness, CANCER patients, NEUROENDOCRINE tumors, SOMATOSTATIN, QUALITY of life, PROGRESSION-free survival, PATIENT safety, LONGITUDINAL method |
مستخلص: |
Simple Summary: Neuroendocrine Tumors are rare cancers with limited therapeutic options. Functioning NETs could produce bioactive peptides leading to a specific syndrome that impacts on patients' quality of life and also on survival—F-NETs patients who are refractory to SSA respond to 177LU-PRRT with a benefit in terms of prognosis. Introduction: Neuroendocrine tumors (NETs) are rare malignancies with different prognoses. At least 25% of metastatic patients have functioning neuroendocrine tumors (F-NETs) that secrete bioactive peptides, causing specific debilitating and occasionally life-threatening symptoms such as diarrhea and flushing. Somatostatin analogs (SSAs) are usually effective but beyond them few treatment options are available. We evaluated the clinical efficacy of 177 Lu-DOTATATE in patients with progressive metastatic F-NETs and SSA-refractory syndrome. Patients and Methods: A non-pre-planned joint analysis was conducted in patients enrolled in phase II clinical trials on metastatic NETs. We extrapolated data from F-NET patients with ≥1 refractory sign/symptom to octreotide, and ≥1 measurable lesion. Syndrome response (SR), overall survival (OS), progression-free survival (PFS), tolerance and disease response were analyzed. Results: Sixty-eight patients were enrolled, the majority (88.1%) with a SR. According to RECIST criteria, 1 (1.5%) patient showed a CR, 21 (32.3%) had a PR and 40 (61.5%) SD. At a median follow-up of 28.9 months (range 2.2–63.2) median PFS was 33.0 months (95%CI: 27.1–48.2). Median OS (mOS) had not been reached at the time of the analysis; the 2-year OS was 87.8% (95%CI: 76.1–94.1). Syndromic responders showed better survival than non-responders, with a 2-year OS of 93.9% (95%CI: 92.2–98.0) vs. 40.0% (95%CI: 6.6–73.4), respectively. A total of 233 adverse events were recorded. Grade 1–2 hematological toxicity was the most frequent. Conclusion: The 177 Lu-DOTATATE improved symptoms and disease control in patients with F-NETs. Treatment was well tolerated. The syndrome had an impact on both quality of life and OS. [ABSTRACT FROM AUTHOR] |
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قاعدة البيانات: |
Complementary Index |