Final results of a randomized phase III trial of induction chemotherapy followed by concurrent chemoradiotherapy versus concurrent chemoradiotherapy alone in patients with stage IVA and IVB nasopharyngeal carcinoma-Taiwan Cooperative Oncology Group (TCOG) 1303 Study

R L Hong; C F Hsiao; L L Ting; J Y Ko; C W Wang; J T C Chang; P J Lou; H M Wang; M H Tsai; S C Lai; T W Liu

doi:10.1093/annonc/mdy249

Final results of a randomized phase III trial of induction chemotherapy followed by concurrent chemoradiotherapy versus concurrent chemoradiotherapy alone in patients with stage IVA and IVB nasopharyngeal carcinoma-Taiwan Cooperative Oncology Group (TCOG) 1303 Study

R L Hong, C F Hsiao, L L Ting, J Y Ko, C W Wang, J T C Chang, P J Lou, H M Wang, M H Tsai, S C Lai, T W Liu

Research output: Contribution to journal › Article › peer-review

82 Citations (Scopus)

Abstract

Background: Concurrent chemoradiotherapy (CCRT) is superior to radiotherapy alone for treating locoregionally advanced nasopharyngeal carcinoma (NPC). Whether adding induction chemotherapy (IC) further improves the outcome warrants investigation.

Patients and methods: This open-label multicenter phase III trial was conducted at 11 institutions in Taiwan. Patients with stage IVA or IVB NPC were randomized to receive IC followed by CCRT (I-CCRT) or CCRT alone. Patients in the I-CCRT arm received 3 cycles of mitomycin C, epirubicin, cisplatin, and 5-fluorouracil/leucovorin (MEPFL). All patients received 30 mg/m2 cisplatin weekly during radiotherapy, which was delivered as 1.8-2.2 Gy per fraction with five daily fractions per week, to a total dose of 70 Gy or greater to the primary tumor and 66-70 Gy to the involved neck. The primary endpoint was disease-free survival (DFS).

Results: In this study, 240 and 239 patients were randomized to CCRT and I-CCRT arm, respectively. The most prominent toxicities of induction were leukopenia (grade 3 and 4: 47% and 12%) and thrombocytopenia (grade 3 and 4: 24% and 3%). During radiotherapy, severe mucositis was the major side effect in both arms; an increased number of patients in the I-CCRT arm had myelosuppression; hence, discontinuation of weekly cisplatin was more common. After a median follow-up of 72.0 months, the I-CCRT arm had significantly higher DFS than that of the CCRT arm (5-year rate 61% vs 50%; hazard ratio = 0·739, 95% confidence interval (CI)= 0·565-0·965; P = 0·0264), after stratified for N3b and LDH, and adjusted for T stage.

Conclusion: Induction with MEPFL before CCRT was tolerable and significantly improved the DFS of patients with stage IVA and IVB NPC though overall survival not improved.

Clinical trial information: NCT00201396.

Original language	English
Pages (from-to)	1972-1979
Number of pages	8
Journal	Annals of Oncology
Volume	29
Issue number	9
Early online date	Jul 17 2018
DOIs	https://doi.org/10.1093/annonc/mdy249
Publication status	Published - Sept 1 2018
Externally published	Yes

Keywords

concurrent chemoradiotherapy
induction chemotherapy
locoregionally advanced
nasopharyngeal carcinoma
phase III study

ASJC Scopus subject areas

Hematology
Oncology

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Hong, R. L., Hsiao, C. F., Ting, L. L., Ko, J. Y., Wang, C. W., Chang, J. T. C., Lou, P. J., Wang, H. M., Tsai, M. H., Lai, S. C., & Liu, T. W. (2018). Final results of a randomized phase III trial of induction chemotherapy followed by concurrent chemoradiotherapy versus concurrent chemoradiotherapy alone in patients with stage IVA and IVB nasopharyngeal carcinoma-Taiwan Cooperative Oncology Group (TCOG) 1303 Study. Annals of Oncology, 29(9), 1972-1979. https://doi.org/10.1093/annonc/mdy249

Final results of a randomized phase III trial of induction chemotherapy followed by concurrent chemoradiotherapy versus concurrent chemoradiotherapy alone in patients with stage IVA and IVB nasopharyngeal carcinoma-Taiwan Cooperative Oncology Group (TCOG) 1303 Study. / Hong, R L; Hsiao, C F; Ting, L L et al.

In: Annals of Oncology, Vol. 29, No. 9, 01.09.2018, p. 1972-1979.

Research output: Contribution to journal › Article › peer-review

Hong, RL, Hsiao, CF, Ting, LL, Ko, JY, Wang, CW, Chang, JTC, Lou, PJ, Wang, HM, Tsai, MH, Lai, SC & Liu, TW 2018, 'Final results of a randomized phase III trial of induction chemotherapy followed by concurrent chemoradiotherapy versus concurrent chemoradiotherapy alone in patients with stage IVA and IVB nasopharyngeal carcinoma-Taiwan Cooperative Oncology Group (TCOG) 1303 Study', Annals of Oncology, vol. 29, no. 9, pp. 1972-1979. https://doi.org/10.1093/annonc/mdy249

Hong RL, Hsiao CF, Ting LL, Ko JY, Wang CW, Chang JTC et al. Final results of a randomized phase III trial of induction chemotherapy followed by concurrent chemoradiotherapy versus concurrent chemoradiotherapy alone in patients with stage IVA and IVB nasopharyngeal carcinoma-Taiwan Cooperative Oncology Group (TCOG) 1303 Study. Annals of Oncology. 2018 Sept 1;29(9):1972-1979. Epub 2018 Jul 17. doi: 10.1093/annonc/mdy249

Hong, R L ; Hsiao, C F ; Ting, L L et al. / Final results of a randomized phase III trial of induction chemotherapy followed by concurrent chemoradiotherapy versus concurrent chemoradiotherapy alone in patients with stage IVA and IVB nasopharyngeal carcinoma-Taiwan Cooperative Oncology Group (TCOG) 1303 Study. In: Annals of Oncology. 2018 ; Vol. 29, No. 9. pp. 1972-1979.

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abstract = "Background: Concurrent chemoradiotherapy (CCRT) is superior to radiotherapy alone for treating locoregionally advanced nasopharyngeal carcinoma (NPC). Whether adding induction chemotherapy (IC) further improves the outcome warrants investigation.Patients and methods: This open-label multicenter phase III trial was conducted at 11 institutions in Taiwan. Patients with stage IVA or IVB NPC were randomized to receive IC followed by CCRT (I-CCRT) or CCRT alone. Patients in the I-CCRT arm received 3 cycles of mitomycin C, epirubicin, cisplatin, and 5-fluorouracil/leucovorin (MEPFL). All patients received 30 mg/m2 cisplatin weekly during radiotherapy, which was delivered as 1.8-2.2 Gy per fraction with five daily fractions per week, to a total dose of 70 Gy or greater to the primary tumor and 66-70 Gy to the involved neck. The primary endpoint was disease-free survival (DFS).Results: In this study, 240 and 239 patients were randomized to CCRT and I-CCRT arm, respectively. The most prominent toxicities of induction were leukopenia (grade 3 and 4: 47% and 12%) and thrombocytopenia (grade 3 and 4: 24% and 3%). During radiotherapy, severe mucositis was the major side effect in both arms; an increased number of patients in the I-CCRT arm had myelosuppression; hence, discontinuation of weekly cisplatin was more common. After a median follow-up of 72.0 months, the I-CCRT arm had significantly higher DFS than that of the CCRT arm (5-year rate 61% vs 50%; hazard ratio = 0·739, 95% confidence interval (CI)= 0·565-0·965; P = 0·0264), after stratified for N3b and LDH, and adjusted for T stage.Conclusion: Induction with MEPFL before CCRT was tolerable and significantly improved the DFS of patients with stage IVA and IVB NPC though overall survival not improved.Clinical trial information: NCT00201396.",

keywords = "concurrent chemoradiotherapy, induction chemotherapy, locoregionally advanced, nasopharyngeal carcinoma, phase III study",

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AU - Hong, R L

AU - Hsiao, C F

AU - Ting, L L

AU - Ko, J Y

AU - Wang, C W

AU - Chang, J T C

AU - Lou, P J

AU - Wang, H M

AU - Tsai, M H

AU - Lai, S C

AU - Liu, T W

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N2 - Background: Concurrent chemoradiotherapy (CCRT) is superior to radiotherapy alone for treating locoregionally advanced nasopharyngeal carcinoma (NPC). Whether adding induction chemotherapy (IC) further improves the outcome warrants investigation.Patients and methods: This open-label multicenter phase III trial was conducted at 11 institutions in Taiwan. Patients with stage IVA or IVB NPC were randomized to receive IC followed by CCRT (I-CCRT) or CCRT alone. Patients in the I-CCRT arm received 3 cycles of mitomycin C, epirubicin, cisplatin, and 5-fluorouracil/leucovorin (MEPFL). All patients received 30 mg/m2 cisplatin weekly during radiotherapy, which was delivered as 1.8-2.2 Gy per fraction with five daily fractions per week, to a total dose of 70 Gy or greater to the primary tumor and 66-70 Gy to the involved neck. The primary endpoint was disease-free survival (DFS).Results: In this study, 240 and 239 patients were randomized to CCRT and I-CCRT arm, respectively. The most prominent toxicities of induction were leukopenia (grade 3 and 4: 47% and 12%) and thrombocytopenia (grade 3 and 4: 24% and 3%). During radiotherapy, severe mucositis was the major side effect in both arms; an increased number of patients in the I-CCRT arm had myelosuppression; hence, discontinuation of weekly cisplatin was more common. After a median follow-up of 72.0 months, the I-CCRT arm had significantly higher DFS than that of the CCRT arm (5-year rate 61% vs 50%; hazard ratio = 0·739, 95% confidence interval (CI)= 0·565-0·965; P = 0·0264), after stratified for N3b and LDH, and adjusted for T stage.Conclusion: Induction with MEPFL before CCRT was tolerable and significantly improved the DFS of patients with stage IVA and IVB NPC though overall survival not improved.Clinical trial information: NCT00201396.

AB - Background: Concurrent chemoradiotherapy (CCRT) is superior to radiotherapy alone for treating locoregionally advanced nasopharyngeal carcinoma (NPC). Whether adding induction chemotherapy (IC) further improves the outcome warrants investigation.Patients and methods: This open-label multicenter phase III trial was conducted at 11 institutions in Taiwan. Patients with stage IVA or IVB NPC were randomized to receive IC followed by CCRT (I-CCRT) or CCRT alone. Patients in the I-CCRT arm received 3 cycles of mitomycin C, epirubicin, cisplatin, and 5-fluorouracil/leucovorin (MEPFL). All patients received 30 mg/m2 cisplatin weekly during radiotherapy, which was delivered as 1.8-2.2 Gy per fraction with five daily fractions per week, to a total dose of 70 Gy or greater to the primary tumor and 66-70 Gy to the involved neck. The primary endpoint was disease-free survival (DFS).Results: In this study, 240 and 239 patients were randomized to CCRT and I-CCRT arm, respectively. The most prominent toxicities of induction were leukopenia (grade 3 and 4: 47% and 12%) and thrombocytopenia (grade 3 and 4: 24% and 3%). During radiotherapy, severe mucositis was the major side effect in both arms; an increased number of patients in the I-CCRT arm had myelosuppression; hence, discontinuation of weekly cisplatin was more common. After a median follow-up of 72.0 months, the I-CCRT arm had significantly higher DFS than that of the CCRT arm (5-year rate 61% vs 50%; hazard ratio = 0·739, 95% confidence interval (CI)= 0·565-0·965; P = 0·0264), after stratified for N3b and LDH, and adjusted for T stage.Conclusion: Induction with MEPFL before CCRT was tolerable and significantly improved the DFS of patients with stage IVA and IVB NPC though overall survival not improved.Clinical trial information: NCT00201396.

KW - concurrent chemoradiotherapy

KW - induction chemotherapy

KW - locoregionally advanced

KW - nasopharyngeal carcinoma

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Final results of a randomized phase III trial of induction chemotherapy followed by concurrent chemoradiotherapy versus concurrent chemoradiotherapy alone in patients with stage IVA and IVB nasopharyngeal carcinoma-Taiwan Cooperative Oncology Group (TCOG) 1303 Study

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