Phase II study of SMILE chemotherapy for newly diagnosed stage IV, relapsed, or refractory extranodal Natural Killer (NK)/T-cell lymphoma, nasal type: The NK-cell tumor study group study

Motoko Yamaguchi, Yok Lam Kwong, Won Seog Kim, Yoshinobu Maeda, Chizuko Hashimoto, Cheolwon Suh, Koji Izutsu, Fumihiro Ishida, Yasushi Isobe, Eisaburo Sueoka, Junji Suzumiya, Takao Kodama, Hiroshi Kimura, Rie Hyo, Shigeo Nakamura, Kazuo Oshimi, Ritsuro Suzuki

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Abstract

Purpose: To explore a more effective treatment for newly diagnosed stage IV, relapsed, or refractory extranodal natural killer/T-cell lymphoma, nasal type (ENKL), we conducted a phase II study of the steroid (dexamethasone), methotrexate, ifosfamide, L-asparaginase, and etoposide (SMILE) regimen. Patients and Methods: Patients with newly diagnosed stage IV, relapsed, or refractory disease and a performance status of 0 to 2 were eligible. Two cycles of SMILE chemotherapy were administered as the protocol treatment. The primary end point was the overall response rate (ORR) after the protocol treatment. Results: A total of 38 eligible patients were enrolled. The median age was 47 years (range, 16 to 67 years), and the male:female ratio was 21:17. The disease status was newly diagnosed stage IV in 20 patients, first relapse in 14 patients, and primary refractory in four patients. The eligibility was revised to include lymphocyte counts of 500/μL or more because the first two patients died from infections. No treatment-related deaths were observed after the revision. The ORR and complete response rate after two cycles of SMILE chemotherapy were 79% (90% CI, 65% to 89%) and 45%, respectively. In the 28 patients who completed the protocol treatment, 19 underwent hematopoietic stem-cell transplantation. The 1-year overall survival rate was 55% (95% CI, 38% to 69%). Grade 4 neutropenia was observed in 92% of the patients. The most common grade 3 or 4 nonhematologic complication was infection (61%). Conclusion: SMILE chemotherapy is an effective treatment for newly diagnosed stage IV, relapsed or refractory ENKL. Myelosuppression and infection during the treatment should be carefully managed.

Original languageEnglish
Pages (from-to)4410-4416
Number of pages7
JournalJournal of Clinical Oncology
Volume29
Issue number33
DOIs
Publication statusPublished - Nov 20 2011

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Asparaginase
Ifosfamide
Natural Killer T-Cells
T-Cell Lymphoma
Etoposide
Nose
Methotrexate
Natural Killer Cells
Dexamethasone
Drug Therapy
Neoplasms
Clinical Protocols
Infection
Hematopoietic Stem Cell Transplantation
Lymphocyte Count
Therapeutics
Neutropenia
Survival Rate
Steroids
Recurrence

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

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Phase II study of SMILE chemotherapy for newly diagnosed stage IV, relapsed, or refractory extranodal Natural Killer (NK)/T-cell lymphoma, nasal type : The NK-cell tumor study group study. / Yamaguchi, Motoko; Kwong, Yok Lam; Kim, Won Seog; Maeda, Yoshinobu; Hashimoto, Chizuko; Suh, Cheolwon; Izutsu, Koji; Ishida, Fumihiro; Isobe, Yasushi; Sueoka, Eisaburo; Suzumiya, Junji; Kodama, Takao; Kimura, Hiroshi; Hyo, Rie; Nakamura, Shigeo; Oshimi, Kazuo; Suzuki, Ritsuro.

In: Journal of Clinical Oncology, Vol. 29, No. 33, 20.11.2011, p. 4410-4416.

Research output: Contribution to journalArticle

Yamaguchi, M, Kwong, YL, Kim, WS, Maeda, Y, Hashimoto, C, Suh, C, Izutsu, K, Ishida, F, Isobe, Y, Sueoka, E, Suzumiya, J, Kodama, T, Kimura, H, Hyo, R, Nakamura, S, Oshimi, K & Suzuki, R 2011, 'Phase II study of SMILE chemotherapy for newly diagnosed stage IV, relapsed, or refractory extranodal Natural Killer (NK)/T-cell lymphoma, nasal type: The NK-cell tumor study group study', Journal of Clinical Oncology, vol. 29, no. 33, pp. 4410-4416. https://doi.org/10.1200/JCO.2011.35.6287
Yamaguchi, Motoko ; Kwong, Yok Lam ; Kim, Won Seog ; Maeda, Yoshinobu ; Hashimoto, Chizuko ; Suh, Cheolwon ; Izutsu, Koji ; Ishida, Fumihiro ; Isobe, Yasushi ; Sueoka, Eisaburo ; Suzumiya, Junji ; Kodama, Takao ; Kimura, Hiroshi ; Hyo, Rie ; Nakamura, Shigeo ; Oshimi, Kazuo ; Suzuki, Ritsuro. / Phase II study of SMILE chemotherapy for newly diagnosed stage IV, relapsed, or refractory extranodal Natural Killer (NK)/T-cell lymphoma, nasal type : The NK-cell tumor study group study. In: Journal of Clinical Oncology. 2011 ; Vol. 29, No. 33. pp. 4410-4416.
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abstract = "Purpose: To explore a more effective treatment for newly diagnosed stage IV, relapsed, or refractory extranodal natural killer/T-cell lymphoma, nasal type (ENKL), we conducted a phase II study of the steroid (dexamethasone), methotrexate, ifosfamide, L-asparaginase, and etoposide (SMILE) regimen. Patients and Methods: Patients with newly diagnosed stage IV, relapsed, or refractory disease and a performance status of 0 to 2 were eligible. Two cycles of SMILE chemotherapy were administered as the protocol treatment. The primary end point was the overall response rate (ORR) after the protocol treatment. Results: A total of 38 eligible patients were enrolled. The median age was 47 years (range, 16 to 67 years), and the male:female ratio was 21:17. The disease status was newly diagnosed stage IV in 20 patients, first relapse in 14 patients, and primary refractory in four patients. The eligibility was revised to include lymphocyte counts of 500/μL or more because the first two patients died from infections. No treatment-related deaths were observed after the revision. The ORR and complete response rate after two cycles of SMILE chemotherapy were 79{\%} (90{\%} CI, 65{\%} to 89{\%}) and 45{\%}, respectively. In the 28 patients who completed the protocol treatment, 19 underwent hematopoietic stem-cell transplantation. The 1-year overall survival rate was 55{\%} (95{\%} CI, 38{\%} to 69{\%}). Grade 4 neutropenia was observed in 92{\%} of the patients. The most common grade 3 or 4 nonhematologic complication was infection (61{\%}). Conclusion: SMILE chemotherapy is an effective treatment for newly diagnosed stage IV, relapsed or refractory ENKL. Myelosuppression and infection during the treatment should be carefully managed.",
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T2 - The NK-cell tumor study group study

AU - Yamaguchi, Motoko

AU - Kwong, Yok Lam

AU - Kim, Won Seog

AU - Maeda, Yoshinobu

AU - Hashimoto, Chizuko

AU - Suh, Cheolwon

AU - Izutsu, Koji

AU - Ishida, Fumihiro

AU - Isobe, Yasushi

AU - Sueoka, Eisaburo

AU - Suzumiya, Junji

AU - Kodama, Takao

AU - Kimura, Hiroshi

AU - Hyo, Rie

AU - Nakamura, Shigeo

AU - Oshimi, Kazuo

AU - Suzuki, Ritsuro

PY - 2011/11/20

Y1 - 2011/11/20

N2 - Purpose: To explore a more effective treatment for newly diagnosed stage IV, relapsed, or refractory extranodal natural killer/T-cell lymphoma, nasal type (ENKL), we conducted a phase II study of the steroid (dexamethasone), methotrexate, ifosfamide, L-asparaginase, and etoposide (SMILE) regimen. Patients and Methods: Patients with newly diagnosed stage IV, relapsed, or refractory disease and a performance status of 0 to 2 were eligible. Two cycles of SMILE chemotherapy were administered as the protocol treatment. The primary end point was the overall response rate (ORR) after the protocol treatment. Results: A total of 38 eligible patients were enrolled. The median age was 47 years (range, 16 to 67 years), and the male:female ratio was 21:17. The disease status was newly diagnosed stage IV in 20 patients, first relapse in 14 patients, and primary refractory in four patients. The eligibility was revised to include lymphocyte counts of 500/μL or more because the first two patients died from infections. No treatment-related deaths were observed after the revision. The ORR and complete response rate after two cycles of SMILE chemotherapy were 79% (90% CI, 65% to 89%) and 45%, respectively. In the 28 patients who completed the protocol treatment, 19 underwent hematopoietic stem-cell transplantation. The 1-year overall survival rate was 55% (95% CI, 38% to 69%). Grade 4 neutropenia was observed in 92% of the patients. The most common grade 3 or 4 nonhematologic complication was infection (61%). Conclusion: SMILE chemotherapy is an effective treatment for newly diagnosed stage IV, relapsed or refractory ENKL. Myelosuppression and infection during the treatment should be carefully managed.

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