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Cancers 2014, 6(4), 2035-2048; doi:10.3390/cancers6042035

Gefitinib Plus Interleukin-2 in Advanced Non-Small Cell Lung Cancer Patients Previously Treated with Chemotherapy

1
Oncology Unit, University Hospital of Parma, Via Gramsci, 14, 43126 Parma, Italy
2
Oncology Unit, Azienda Istituti Ospitalieri di Cremona, Largo Priori, 1, 26100 Cremona, Italy
3
Radiology Division, Spedali Civili di Brescia, P.le Spedali Civili,1, 25123 Brescia, Italy
*
Author to whom correspondence should be addressed.
Received: 28 June 2014 / Revised: 21 August 2014 / Accepted: 15 September 2014 / Published: 30 September 2014
(This article belongs to the Special Issue Cancer Drug Resistance)
View Full-Text   |   Download PDF [546 KB, uploaded 30 September 2014]   |  

Abstract

The activation of lymphocytes by gefitinib treatment has been described. In this phase II pilot trial, we explored the possible synergism between IL-2 and gefitinib for non-small cell lung cancer (NSCLC) treatment. From September, 2003, to November, 2006, 70 consecutive patients with advanced, progressive NSCLC, previously treated with chemotherapy, received oral gefitinib 250 mg daily. The first 39 patients received gefitinib alone (G group). The other 31 also received subcutaneous IL-2 (GIL-2 group): 1 MIU/m2 (Million International Unit/m2)twice a day on Days 1 and 2, once a day on Days 3, 4, 5 every week for four consecutive weeks with a four-week rest period. Median follow-up was 25.2 months. Grade 3–4 toxicity of gefitinib was represented by skin rash (7%), asthenia/anorexia (6%) and diarrhea (7%); patients treated with IL-2 showed grade 2–3 fever (46%), fatigue (21%) and arthralgia (13%). In the GIL-2 group and G-group, we respectively observed: an overall response rate of 16.1% (6.4% complete response) and 5.1% (only partial response); a disease control rate of 41.9% and 41%; a median time to progression of 3.5 (CI 95% = 3.2–3.8) and 4.1 (CI 95% = 2.6–5.7) months; a median overall survival of 20.1 (CI 95% = 5.1–35.1) and 6.9 (CI 95% = 4.9–8.9) months (p = 0.002); and an actuarial one-year survival rate of 54% and 30%. Skin toxicity (p < 0.001; HR = 0.29; CI 95% = 0.16–0.54) and use of IL-2 (p < 0.001; HR = 0.33; CI 95% = 0.18–0.60) were independently associated with improvement of survival. In this consecutive, non-randomized, series of advanced NSCLC patients, the use of IL-2 increased the efficacy of gefitinib. View Full-Text
Keywords: gefitinib; interleukin-2; IL-2; lung cancer; non-small cell lung cancer; NSCLC; immunotherapy; tyrosine kinase inhibitors; TKI gefitinib; interleukin-2; IL-2; lung cancer; non-small cell lung cancer; NSCLC; immunotherapy; tyrosine kinase inhibitors; TKI
This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. (CC BY 4.0).

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MDPI and ACS Style

Bersanelli, M.; Buti, S.; Camisa, R.; Brighenti, M.; Lazzarelli, S.; Mazza, G.; Passalacqua, R. Gefitinib Plus Interleukin-2 in Advanced Non-Small Cell Lung Cancer Patients Previously Treated with Chemotherapy. Cancers 2014, 6, 2035-2048.

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