Open Access

Chemotherapy with or without low-dose interleukin-2 in advanced non-small cell lung cancer: results from a phase III randomized multicentric trial

  • Authors: Laura Ridolfi, Oscar Bertetto, Antonio Santo, Emanuele Naglieri, Massimo Lopez, Francesco Recchia, Paolo Lissoni, Marco Galliano, Franco Testore, Camillo Porta, Monica Maglie, Monia Dall'agata, Luca Fumagalli, Ruggero Ridolfi
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  • Published online on: Friday, June 24, 2011
  • Pages: 1011-1017
  • DOI: 10.3892/ijo.2011.1099

Abstract

Non-small cell lung cancer (NSCLC) is associated with IL-2-dependent cell-mediated immunodeficiency. As IL-2 is the main lymphocyte growth factor, a phase III randomized multicenter trial was conducted to evaluate the impact of subcutaneous low-dose IL-2 added to standard chemotherapy (CT) on overall survival (OS) in advanced NSCLC patients. Patients (n=241) with histologically confirmed stage IIIb or IV non-operable NSCLC underwent stratified randomization on the basis of center, ECOG PS, stage of disease and percentage of weight loss. Patients received gemcitabine (1000 mg/m2) on days 1 and 8 + cisplatin (100 mg/m2) on day 2 every 21 days for a maximum of 6 cycles [chemotherapy (CT) arm]. In the CT+IL-2 arm, patients also received low-dose subcutaneous IL-2 3,000,000 IU/die on days 3-5, 9-11, 15-17. The study had 90% power to detect a 20% absolute increase in 1-year OS with 118 patients/arm. An overall response (OR) rate of 12.8% (14% in the CT+IL-2 arm and 11.4% in CT arm) was observed. Stable disease was 70 and 66.7%, and progressive disease 16 and 21.8% in the CT+IL-2 and CT arms, respectively. No differences in response were found in any subgroup analysis. At a median follow-up of 32 months, 1-year OS was 45% for the CT+IL-2 arm vs. 51% for the CT arm (p=0.456 log-rank). Median progression-free survival was 6.6 months in the CT+IL-2 arm vs. 6.9 months in the CT arm (p=0.573, log-rank). A higher number of grade 4 toxicities were reported with CT+IL-2. The most common grade ≥3 adverse events were gastrointestinal toxicity (mainly nausea and diarrhea) and myelosuppression. No relevant differences in clinical outcome were observed from the addition of IL-2 to CT. Future studies investigating the role of T-regulators in chemoimmunotherapeutic regimens could be performed.
Journal Cover

October 2011
Volume 39 Issue 4

Print ISSN: 1019-6439
Online ISSN:1791-2423

2012 Impact Factor: 2.657
Ranked #31/196 Oncology
(total number of cites)

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APA
Ridolfi, L., Bertetto, O., Santo, A., Naglieri, E., Lopez, M., Recchia, F., Lissoni, P., Galliano, M., Testore, F., Porta, C., Maglie, M., Dall'agata, M., Fumagalli, L., & Ridolfi, R. (2011). Chemotherapy with or without low-dose interleukin-2 in advanced non-small cell lung cancer: results from a phase III randomized multicentric trial. International Journal of Oncology, 39(4), 1011-1017.
MLA
Ridolfi, Bertetto, Santo, Naglieri, Lopez, Recchia, Lissoni, Galliano, Testore, Porta, Maglie, Dall'agata, Fumagalli, and Ruggero Ridolfi. "Chemotherapy with or without low-dose interleukin-2 in advanced non-small cell lung cancer: results from a phase III randomized multicentric trial." International Journal of Oncology International Journal of Oncology 39.4 (2011): 1011-1017.
Chicago
Ridolfi, Bertetto, Santo, Naglieri, Lopez, Recchia, Lissoni, Galliano, Testore, Porta, Maglie, Dall'agata, Fumagalli, and Ruggero Ridolfi. "Chemotherapy with or without low-dose interleukin-2 in advanced non-small cell lung cancer: results from a phase III randomized multicentric trial." International Journal of Oncology International Journal of Oncology 39 no. 4 (2011): 1011-1017.