A phase II trial of induction gemcitabine and vinorelbine followed by concurrent vinorelbine and radiotherapy in locally advanced non-small cell lung cancer

Leong, S. S.; Fong, Kam Weng; Lim, Darren Wan-Teck; Toh, Chee-Keong; Yap, Swee Peng; Hee, Siew Wan; Tan, Eng Huat

doi:10.1016/j.lungcan.2009.04.022

Cited by 8 publications

(6 citation statements)

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“…of 41 assessable patients who were treated with induction two cycles of carboplatin and gemcitabine 73.1% achieved PR and 24.4% SD 20. Other publications from recent years showed lower PR and SD of 37% and 50% after two cycles of induction cisplatin and oral vinorelbine21, PR and SD of 36% and 52% after two cycles of induction gemcitabine and vinorelbine22, and PR and SD of 32.1% and 44.6% after two cycles of induction cisplatin and docetaxel 23…”

Section: Discussionmentioning

confidence: 97%

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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

Vrankar

Zwitter

Bavcar

et al. 2014

Radiology and Oncology

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Disclosure: No potential conflicts of interest were disclosed.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/m 2 in a standard half hour i.v. infusion on days 1 and 8; patients in arm B received gemcitabine at 250 mg/m 2 in prolonged 6-hours i.v. infusion on days 1 and 8. In both arms, cisplatin 75 mg/m 2 on day 2 was administered. All patients continued treatment with radiation therapy with 60-66 Gy concurrent with cisplatin 50 mg/m 2 on days 1, 8, 29 and 36 and etoposid 50 mg/m 2 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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Section: Discussionmentioning

confidence: 97%

“…Trials with concurrent radiochemotherapy in combination with induction or consolidation chemotherapy using platinum-based combinations report median survival in the range of 13 to 29.5 months19–23,26–29, 3-year survival in the range of 13% to 39.8%22,27 and 5-year survival in the range of 12.5% to 22% 19,26,29…”

Section: Discussionmentioning

confidence: 99%

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

Vrankar

Zwitter

Bavcar

et al. 2014

Radiology and Oncology

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“…In recent years, there were several attempts to improve results of treatment locally advanced NSCLC. Trials with concurrent radiochemotherapy in combination with induction or consolidation chemotherapy using platinum-based combinations report median survival in the range of 13 to 29.5 months 19 – 23 , 26 – 29 , 3-year survival in the range of 13% to 39.8% 22 , 27 and 5-year survival in the range of 12.5% to 22%. 19 , 26 , 29 …”

Section: Discussionmentioning

confidence: 99%

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

2014

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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/m 2 in a standard half hour i.v. infusion on days 1 and 8; patients in arm B received gemcitabine at 250 mg/m 2 in prolonged 6-hours i.v. infusion on days 1 and 8. In both arms, cisplatin 75 mg/m 2 on day 2 was administered. All patients continued treatment with radiation therapy with 60–66 Gy concurrent with cisplatin 50 mg/m 2 on days 1, 8, 29 and 36 and etoposid 50 mg/m 2 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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“…Moreover, vinorelbine has shown encouraging activity and an acceptable toxicity profile in several Phase II studies of sequential [52][53][54] or concurrent [55][56][57][58] chemoradiotherapy or induction chemotherapy followed by concurrent chemo-radiotherapy [59,60].…”

Section: Vinorelbine In Combination With Radiotherapymentioning

confidence: 99%

Vinorelbine for non-small cell lung cancer

Piccirillo

Daniele

Maïo

et al. 2010

Expert Opinion on Drug Safety

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A phase II trial of induction gemcitabine and vinorelbine followed by concurrent vinorelbine and radiotherapy in locally advanced non-small cell lung cancer

Cited by 8 publications

References 37 publications

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

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

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

Vinorelbine for non-small cell lung cancer

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