| Title: | Induction gemcitabine in standard dose or prolonged low-dose with cisplatin followed by concurrent radiochemotherapy in locally advanced non-small cell lung cancer : a randomized phase II clinical trial |
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| Authors: | ID Vrankar, Martina (Author)
ID Zwitter, Matjaž (Author)
ID Bavčar-Vodovnik, Tanja (Author)
ID Milič, Ana (Author)
ID Kovač, Viljem (Author) |
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| Files: |  Radiology_and_Oncology_2014_Vrankar_et_al._Induction_gemcitabine_in_standard_dose_or_prolonged_low-dose_with_cisplatin_followed_by_concu.pdf (752,07 KB)
MD5: 07C698805B4685CAFCB1F51555DE5084
 http://www.degruyter.com/view/j/raon.2014.48.issue-4/raon-2014-0026/raon-2014-0026.xml
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| Language: | English |
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| Work type: | Scientific work |
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| Typology: | 1.01 - Original Scientific Article |
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| Organization: | MF - Faculty of Medicine
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| Abstract: | Background: The optimal combination of chemotherapy with radiation therapy for treatment locally advanced non-small cell lung cancer (NSCLC) remains an open issue. This randomized phase II study compared gemcitabine in two different schedules and cisplatin - as induction chemotherapy, followed by radiation therapy concurrent with cisplatin and etoposid.
Patients and methods: Eligible patients had microscopically confirmed inoperable non-metastatic non-small cell lung cancer; fulfilled the standard criteria for platin-based chemotherapy; and signed informed consent. Patients were treated with 3 cycles of induction chemotherapy with gemcitabine and cisplatin. Two different aplications of gemcitabine were compared: patients in arm A received gemcitabine at 1250 mg/m2 in a standard half hour i.v. infusion on days 1 and 8; patients in arm B received gemcitabine at 250 mg/m2 in prolonged 6-hours i.v. infusion on days 1 and 8. In both arms, cisplatin 75 mg/m2 on day 2 was administered. All patients continued treatment with radiation therapy with 60-66 Gy concurrent with cisplatin 50 mg/m2 on days 1, 8, 29 and 36 and etoposid 50 mg/m2 on days 1-5 and 29-33. The primary endpoint was response rate (RR) after induction chemotherapy; secondary endpoints were toxicity, progression-free survival (PFS) and overall survival (OS).
Results: From September 2005 to November 2010, 106 patients were recruited to this study. No statistically signifficant differences were found in RR after induction chemotherapy between the two arms (48.1% and 57.4%, p = 0.34). Toxicity profile was comparable and mild with grade 3/4 neutropenia as primary toxicity in both arms. One patient in arm B suffered from acute peripheral ischemia grade 4 and an amputation of lower limb was needed. With a median follow-up of 69.3 months, progression-free survival and median survival in arm A were 15.7 and 24.8 months compared to 18.9 and 28.6 months in arm B. The figures for 1- and 3-year overall survival were 73.1% and 30.8% in arm A, and 81.5 % and 44.4% in arm B, respectively.
Conclusions: Among the two cisplatin-based doublets of induction chemotherapy for inoperable NSCLC, both schedules of gemcitabine have a comparable toxicity profile. Figures for RR, PFS and OS are among the best reported in current literature. While there is a trend towards better efficacy of the treament with prolonged infusion of gemcitabine, the difference between the two arms did not reach statistical significance. |
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| Keywords: | induction chemotherapy, non-small cell lung cancer, radiation therapy, randomized clinical trial |
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| Publication status: | Published |
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| Publication version: | Version of Record |
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| Year of publishing: | 2014 |
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| Number of pages: | str. 369-380, IV |
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| Numbering: | Letn. 48, št. 4 |
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| PID: | 20.500.12556/DKUM-65439  |
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| ISSN: | 1318-2099 |
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| UDC: | 616.2-006 |
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| ISSN on article: | 1318-2099 |
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| COBISS.SI-ID: | 1882491 |
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| DOI: | 10.2478/raon-2014-0026 |
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| NUK URN: | URN:SI:UM:DK:RGZB6D36 |
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| Publication date in DKUM: | 05.04.2017 |
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| Views: | 1505 |
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| Downloads: | 190 |
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| Metadata: |    |
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| Categories: | Misc.
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