A randomized phase II trial of ERCC1 and RRM1 mRNA expression-based chemotherapy versus docetaxel/carboplatin in advanced non-small cell lung cancer

Su Jin Heo, Inkyung Jung, Choong Kun Lee, Jee Hung Kim, Sun Min Lim, Yong Wha Moon, Hyo Sup Shim, Jaeheon Jeong, Joo Hang Kim, Hye Ryun Kim, ByoungChul Cho

Research output: Contribution to journalArticle

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Abstract

Objectives: To evaluate whether the selection of first-line chemotherapy based on ERCC1 and RRM1 mRNA expression levels would improve clinical outcomes in advanced non-small cell lung cancer (NSCLC) patients. Materials and methods: Eligible patients were randomly assigned 1:1 to the experimental and control arms; the experimental arm received gemcitabine/carboplatin (GC) if ERCC1 and RRM1 expression was low, gemcitabine/vinorelbine (GV) if ERCC1 was high and RRM1 was low, docetaxel/carboplatin (DC) if ERCC1 was low and RRM1 was high, and docetaxel/vinorelbine (DV) if both were high. In the control arm, patients received DC. Results: This study was prematurely terminated after the futility analysis of 43 progression-free survival (PFS) events. A total of 55 patients (n = 26 in the experimental arm, n = 29 in the control arm) were evaluable for efficacy and toxicity. Nineteen (73.1 %) patients were assigned to receive GC, 0 (0.0 %) to GV, 4 (15.4 %) to DC, and 3 (11.5 %) to DV in the experimental arm. The overall response rates were 42.3 and 48.3 % in the experimental and control arms, respectively, which were not statistically different (P = 0.657). The median PFS was 5.2 months in the experimental arm and 5.4 months in the control arm (P = 0.286). The median overall survival was 17.4 months in the experimental arm and 12.6 months in the control arm (P = 0.638). The occurrence of grade 3 or higher neutropenia (69.2 vs. 93.1 %, P = 0.035) and febrile neutropenia (3.8 vs. 24.1 %, P = 0.054) was more common in the control arm. Conclusion: ERCC1 and RRM1 mRNA expression-based chemotherapy did not improve clinical outcomes in advanced NSCLC (NCT01648517).

Original languageEnglish
Pages (from-to)539-548
Number of pages10
JournalCancer Chemotherapy and Pharmacology
Volume77
Issue number3
DOIs
Publication statusPublished - 2016 Mar 1

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docetaxel
gemcitabine
Chemotherapy
Carboplatin
Non-Small Cell Lung Carcinoma
Cells
Drug Therapy
Messenger RNA
Disease-Free Survival
Medical Futility
Febrile Neutropenia
Neutropenia
Toxicity
Survival
vinorelbine

All Science Journal Classification (ASJC) codes

  • Oncology
  • Toxicology
  • Pharmacology
  • Cancer Research
  • Pharmacology (medical)

Cite this

Heo, Su Jin ; Jung, Inkyung ; Lee, Choong Kun ; Kim, Jee Hung ; Lim, Sun Min ; Moon, Yong Wha ; Shim, Hyo Sup ; Jeong, Jaeheon ; Kim, Joo Hang ; Kim, Hye Ryun ; Cho, ByoungChul. / A randomized phase II trial of ERCC1 and RRM1 mRNA expression-based chemotherapy versus docetaxel/carboplatin in advanced non-small cell lung cancer. In: Cancer Chemotherapy and Pharmacology. 2016 ; Vol. 77, No. 3. pp. 539-548.
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abstract = "Objectives: To evaluate whether the selection of first-line chemotherapy based on ERCC1 and RRM1 mRNA expression levels would improve clinical outcomes in advanced non-small cell lung cancer (NSCLC) patients. Materials and methods: Eligible patients were randomly assigned 1:1 to the experimental and control arms; the experimental arm received gemcitabine/carboplatin (GC) if ERCC1 and RRM1 expression was low, gemcitabine/vinorelbine (GV) if ERCC1 was high and RRM1 was low, docetaxel/carboplatin (DC) if ERCC1 was low and RRM1 was high, and docetaxel/vinorelbine (DV) if both were high. In the control arm, patients received DC. Results: This study was prematurely terminated after the futility analysis of 43 progression-free survival (PFS) events. A total of 55 patients (n = 26 in the experimental arm, n = 29 in the control arm) were evaluable for efficacy and toxicity. Nineteen (73.1 {\%}) patients were assigned to receive GC, 0 (0.0 {\%}) to GV, 4 (15.4 {\%}) to DC, and 3 (11.5 {\%}) to DV in the experimental arm. The overall response rates were 42.3 and 48.3 {\%} in the experimental and control arms, respectively, which were not statistically different (P = 0.657). The median PFS was 5.2 months in the experimental arm and 5.4 months in the control arm (P = 0.286). The median overall survival was 17.4 months in the experimental arm and 12.6 months in the control arm (P = 0.638). The occurrence of grade 3 or higher neutropenia (69.2 vs. 93.1 {\%}, P = 0.035) and febrile neutropenia (3.8 vs. 24.1 {\%}, P = 0.054) was more common in the control arm. Conclusion: ERCC1 and RRM1 mRNA expression-based chemotherapy did not improve clinical outcomes in advanced NSCLC (NCT01648517).",
author = "Heo, {Su Jin} and Inkyung Jung and Lee, {Choong Kun} and Kim, {Jee Hung} and Lim, {Sun Min} and Moon, {Yong Wha} and Shim, {Hyo Sup} and Jaeheon Jeong and Kim, {Joo Hang} and Kim, {Hye Ryun} and ByoungChul Cho",
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A randomized phase II trial of ERCC1 and RRM1 mRNA expression-based chemotherapy versus docetaxel/carboplatin in advanced non-small cell lung cancer. / Heo, Su Jin; Jung, Inkyung; Lee, Choong Kun; Kim, Jee Hung; Lim, Sun Min; Moon, Yong Wha; Shim, Hyo Sup; Jeong, Jaeheon; Kim, Joo Hang; Kim, Hye Ryun; Cho, ByoungChul.

In: Cancer Chemotherapy and Pharmacology, Vol. 77, No. 3, 01.03.2016, p. 539-548.

Research output: Contribution to journalArticle

TY - JOUR

T1 - A randomized phase II trial of ERCC1 and RRM1 mRNA expression-based chemotherapy versus docetaxel/carboplatin in advanced non-small cell lung cancer

AU - Heo, Su Jin

AU - Jung, Inkyung

AU - Lee, Choong Kun

AU - Kim, Jee Hung

AU - Lim, Sun Min

AU - Moon, Yong Wha

AU - Shim, Hyo Sup

AU - Jeong, Jaeheon

AU - Kim, Joo Hang

AU - Kim, Hye Ryun

AU - Cho, ByoungChul

PY - 2016/3/1

Y1 - 2016/3/1

N2 - Objectives: To evaluate whether the selection of first-line chemotherapy based on ERCC1 and RRM1 mRNA expression levels would improve clinical outcomes in advanced non-small cell lung cancer (NSCLC) patients. Materials and methods: Eligible patients were randomly assigned 1:1 to the experimental and control arms; the experimental arm received gemcitabine/carboplatin (GC) if ERCC1 and RRM1 expression was low, gemcitabine/vinorelbine (GV) if ERCC1 was high and RRM1 was low, docetaxel/carboplatin (DC) if ERCC1 was low and RRM1 was high, and docetaxel/vinorelbine (DV) if both were high. In the control arm, patients received DC. Results: This study was prematurely terminated after the futility analysis of 43 progression-free survival (PFS) events. A total of 55 patients (n = 26 in the experimental arm, n = 29 in the control arm) were evaluable for efficacy and toxicity. Nineteen (73.1 %) patients were assigned to receive GC, 0 (0.0 %) to GV, 4 (15.4 %) to DC, and 3 (11.5 %) to DV in the experimental arm. The overall response rates were 42.3 and 48.3 % in the experimental and control arms, respectively, which were not statistically different (P = 0.657). The median PFS was 5.2 months in the experimental arm and 5.4 months in the control arm (P = 0.286). The median overall survival was 17.4 months in the experimental arm and 12.6 months in the control arm (P = 0.638). The occurrence of grade 3 or higher neutropenia (69.2 vs. 93.1 %, P = 0.035) and febrile neutropenia (3.8 vs. 24.1 %, P = 0.054) was more common in the control arm. Conclusion: ERCC1 and RRM1 mRNA expression-based chemotherapy did not improve clinical outcomes in advanced NSCLC (NCT01648517).

AB - Objectives: To evaluate whether the selection of first-line chemotherapy based on ERCC1 and RRM1 mRNA expression levels would improve clinical outcomes in advanced non-small cell lung cancer (NSCLC) patients. Materials and methods: Eligible patients were randomly assigned 1:1 to the experimental and control arms; the experimental arm received gemcitabine/carboplatin (GC) if ERCC1 and RRM1 expression was low, gemcitabine/vinorelbine (GV) if ERCC1 was high and RRM1 was low, docetaxel/carboplatin (DC) if ERCC1 was low and RRM1 was high, and docetaxel/vinorelbine (DV) if both were high. In the control arm, patients received DC. Results: This study was prematurely terminated after the futility analysis of 43 progression-free survival (PFS) events. A total of 55 patients (n = 26 in the experimental arm, n = 29 in the control arm) were evaluable for efficacy and toxicity. Nineteen (73.1 %) patients were assigned to receive GC, 0 (0.0 %) to GV, 4 (15.4 %) to DC, and 3 (11.5 %) to DV in the experimental arm. The overall response rates were 42.3 and 48.3 % in the experimental and control arms, respectively, which were not statistically different (P = 0.657). The median PFS was 5.2 months in the experimental arm and 5.4 months in the control arm (P = 0.286). The median overall survival was 17.4 months in the experimental arm and 12.6 months in the control arm (P = 0.638). The occurrence of grade 3 or higher neutropenia (69.2 vs. 93.1 %, P = 0.035) and febrile neutropenia (3.8 vs. 24.1 %, P = 0.054) was more common in the control arm. Conclusion: ERCC1 and RRM1 mRNA expression-based chemotherapy did not improve clinical outcomes in advanced NSCLC (NCT01648517).

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