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Curti, Brendan; Crittenden, Marka; Seung, Steven K; Fountain, Christopher B; Payne, Roxanne; Chang, ShuChing; Fleser, Jessica; Phillips, Kimberly; Malkasian, Ian; Dobrunick, Lyn B; Urba, Walter J

Randomized phase II study of stereotactic body radiotherapy and interleukin-2 versus interleukin-2 in patients with metastatic melanoma

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  • Medientyp: E-Artikel
  • Titel: Randomized phase II study of stereotactic body radiotherapy and interleukin-2 versus interleukin-2 in patients with metastatic melanoma
  • Beteiligte: Curti, Brendan; Crittenden, Marka; Seung, Steven K; Fountain, Christopher B; Payne, Roxanne; Chang, ShuChing; Fleser, Jessica; Phillips, Kimberly; Malkasian, Ian; Dobrunick, Lyn B; Urba, Walter J
  • Erschienen: BMJ, 2020
  • Erschienen in: Journal for ImmunoTherapy of Cancer
  • Sprache: Englisch
  • DOI: 10.1136/jitc-2020-000773
  • ISSN: 2051-1426
  • Entstehung:
  • Anmerkungen:
  • Beschreibung: <jats:sec><jats:title>Background</jats:title><jats:p>A pilot study of stereotactic body radiation therapy (SBRT) followed by high-dose interleukin-2 (IL-2) showed a higher than anticipated objective response rate (ORR) among patients with metastatic melanoma (MM). We performed a prospective randomized study to determine if the ORR of SBRT + IL-2 was greater than IL-2 monotherapy in patients with advanced melanoma.</jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p>Patients with MM who had adequate physiological reserve for IL-2 and at least one site suitable for SBRT were eligible. There was a 1:1 randomization to SBRT + IL-2 or IL-2 monotherapy. Patients received one or two doses of SBRT (20 Gy per fraction) with the last dose administered 3 days before starting the first cycle of IL-2. IL-2 (600,000 IU per kg via intravenous bolus infusion) was given every 8 hours for a maximum of 14 doses with a second cycle after a 2-week rest. Responding patients received up to six IL-2 cycles. Patients assigned to IL-2 monotherapy who exhibited progression of melanoma after cycle 2 were allowed to crossover and receive SBRT and additional IL-2. Response Evaluation Criteria in Solid Tumors 1.1 criteria were applied to non-irradiated lesions for response assessment.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>44 patients were included in the analysis. The ORR in the SBRT + IL-2 group was 54%: 21% complete response (CR), 33% partial response (PR), 21% stable disease (SD) and 25% progressive disease (PD). The ORR in patients receiving IL-2 monotherapy was 35%: 15% CR, 20% PR, 25% SD and 40% PD. Seven patients assigned to IL-2 subsequently received SBRT + IL-2. One CR and two PRs were observed in the crossover group. There was no difference in progression-free or overall survival (OS). At 5 years the OS was 26% in the SBRT + IL-2 group and 25% in the IL-2 monotherapy group. The disease control rate (DCR) was higher in the SBRT + IL-2 group (75% vs 60%, p=0.34).</jats:p></jats:sec><jats:sec><jats:title>Conclusions</jats:title><jats:p>SBRT + IL-2 induced more objective responses with a higher DCR compared to IL-2 monotherapy in MM. IL-2 monotherapy resulted in a significantly higher ORR than anticipated. Some patients in the crossover group also achieved objective responses.</jats:p></jats:sec><jats:sec><jats:title>Trial registration number</jats:title><jats:p><jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="clintrialgov" xlink:href="NCT01416831">NCT01416831</jats:ext-link>.</jats:p></jats:sec>
  • Zugangsstatus: Freier Zugang