Phase I/II Trial of Concurrent Use of S-1 and Radiation Therapy for T2 Glottic Cancer

Nakayama, Meijin; Hayakawa, Kazushige; Okamoto, Makito; Niibe, Yuzuru; Ishiyama, Hiromichi; Kotani, Shouko

doi:10.1093/jjco/hyq077

Cited by 33 publications

(18 citation statements)

References 13 publications

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“…To improve the LCR with primary RT and to minimize the need for salvage surgery, clinicians have performed CCRT for Stage II SCC of the glottic larynx, and retrospective reports have found it to be effective (32 -36). Although there has been a prospective examination of CCRT for Stage II SCC of the glottic larynx as a Phase II study, the sample size was not calculated to evaluate the LCR (25). Therefore, the present Phase II study of CCRT with S-1 was performed in patients with Stage II SCC of the pharynx or larynx with LCR as the primary endpoint.…”

Section: Discussionmentioning

confidence: 99%

Phase II Study of Concurrent Chemoradiotherapy with S-1 in Patients with Stage II (T2N0M0) Squamous Cell Carcinoma of the Pharynx or Larynx

Taguchi

Takahashi

Nishimura

et al. 2014

Japanese Journal of Clinical Oncology

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Objective: The goals of treatment for head and neck cancer are cure and organ-function preservation. For organ preservation, primary treatment via radiotherapy alone is thought to be insufficient for Stage II squamous cell carcinoma of the larynx, oropharynx or hypopharynx. The objective of the present study was to investigate the efficacy and safety of concurrent chemoradiotherapy with S-1 for patients with Stage II squamous cell carcinoma of the pharynx or larynx for primary organ preservation. Methods: Previously untreated patients with Stage II squamous cell carcinoma of the larynx, oropharynx or hypopharynx received three courses of S-1 (40 or 50 mg twice a day; 2 weeks of administration followed by 1 week of rest every 3 weeks) during conventional radiotherapy (a single daily fraction of 1.8 Gy) to a total dose of 70.2 Gy. The primary endpoint was the local control rate at 3 years. Results: From August 2009 to October 2012, 37 patients were evaluated for the study. The overall response rate was 100%. The 3-year local control rate was 89.0% (95% confidence interval, 78.9 -99.2%), and the 3-year overall survival rate was 97.2% (95% confidence interval, 91.8 -100%). Mucositis and dermatitis in the radiation field were the most common acute adverse events observed. The rates of Grade 3 mucositis and dermatitis were 27 and 35%, respectively. No patients experienced Grade 4 acute adverse events. The treatment completion rate was 89.2%. Conclusion: Concurrent chemoradiotherapy with S-1 was safe and effective in improving local control for Stage II squamous cell carcinoma of the pharynx or larynx.

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Section: Discussionmentioning

confidence: 99%

Phase II Study of Concurrent Chemoradiotherapy with S-1 in Patients with Stage II (T2N0M0) Squamous Cell Carcinoma of the Pharynx or Larynx

Taguchi

Takahashi

Nishimura

et al. 2014

Japanese Journal of Clinical Oncology

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“…The difference from our study is that their total radiation dose was only 40 Gy because they were giving preoperative concurrent chemoradiotherapy. There have been other reports on Phase III trials of radiotherapy with S-1 [19][20][21][22][23] or the combination of S-1 and cisplatin/nedaplatin [24][25][26] for head and neck cancer. These studies have demonstrated that S-1 and concurrent radical radiotherapy is safe and well tolerated by patients with complications and is a patient-friendly treatment.…”

Section: Discussionmentioning

confidence: 99%

Phase I Study of Oral S-1 and Concurrent Radiotherapy in Patients with Head and Neck Cancer

Nakata

Someya

Takagi

et al. 2010

International Journal of Radiation Oncology*Biology*Physics

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This study investigated the maximum tolerated dose (MTD) of S-1 with concurrent radiotherapy in patients with head and neck cancer, based on the frequency of dose-limiting toxicities (DLT). S-1 was administered orally at escalating doses from 40 mg/m 2 b.i.d. on the days of delivering radiotherapy, which was given at a total dose of 64-70 Gy in 32-35 fractions over 6-7 weeks. A total of 12 patients (3 patients at 40 mg/m Among the 12 enrolled patients, 9 (75%) showed a complete response and 3 (25%) showed a partial response. The overall response rate was 100%. The recommended dose of S-1 with concurrent radiotherapy is 60 mg/m 2 .

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“…Also, in the European Organization for Research and Treatment of Cancer Phase III, randomized trial, 60 Gy-based CCRT (experimental arm) revealed comparative effects on larynx preservation and survival over a 70 Gy-based CCRT (control arm) (18). Even though 70 Gy is the standard adopted RT dose today, we have reported a favorable oncologic outcome with 60 Gy-based S1RT in T2 glottic cancers (19); the present study, including extended phase II S1RT analysis, reconfirmed the effectiveness of our S1RT regimen. Reports from other institutes have also advocated CCRT over RT in early laryngeal cancers (20,21).…”

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confidence: 81%

“…Reports from other institutes have also advocated CCRT over RT in early laryngeal cancers (20,21). We preferred to use 5-FU derivatives because (i) an orally available agent combined with 60 Gy RT enables most of the patients to be treated at an outpatient setting, (ii) the regimen has demonstrated satisfactory treatment effect with limited toxicities (19) and (iii) most of the patients maintained good quality of life. However, considering the intermediate follow-up duration of S1RT regimen, continuing efforts must be paid to detect the occurrence of late adverse events.…”

mentioning

confidence: 99%

Clinical Outcomes of 849 Laryngeal Cancers Treated in the Past 40 Years: Are We Succeeding?

Nakayama

Okamoto

Hayakawa

et al. 2013

Japanese Journal of Clinical Oncology

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Objective: We analyzed the clinical outcomes of 849 laryngeal cancers treated in the past 40 years, which overlapped with the era of the global treatment shift. Methods: To compare the chronological outcomes, patients were divided into four groups according to their registration year as 1972 -82, 1983 -92, 1993 -2002 and 2003 -12; treatment trends, larynx preservation rate and overall survival rate were compared. Results: There were 104, 173, 253 and 319 patients registered in 1972 -82, 1983 -92, 1993 -2002 and 2003 -12, respectively. Five-year overall survival rates were 74, 76.5, 75.6 and 82.2% in 1972 -82, 1983 -92, 1993 -2002 and 2003 -12, respectively. The five-year larynx preservation rates were 65.5, 75.7, 75.4 and 80.9% in 1972 -82, 1983 -92, 1993 -2002 and 2003 -12, respectively. Conclusions: The number of patients treated at our institute increased, and the overall survival and larynx preservation rates exhibited favorable improvements over the past four decades. In the analysis of nonsurgical options, S1 combined radiotherapy showed superiority over concurrent chemoradiotherapy and radiotherapy in larynx preservation, and S1 combined radiotherapy, concurrent chemoradiotherapy and Tegafur Uracil combined radiotherapy showed superiority over radiotherapy in overall survival. In nonsurgical approaches, proper case selection is the key to success and may be much more important than pursuing radiotherapy dose escalation. In the analysis of surgical options, laser and supracricoid laryngectomy with cricohyoidoepiglottopexy contributed to larynx preservation in early-and intermediate-stage cancers, respectively. Supracricoid laryngectomy with cricohyoidoepiglottopexy demonstrated overall survival not worse than total laryngectomy, which is the prerequisite treatment basis for larynx preservation options. We must make extra efforts in pursuing an ideal balance between nonsurgical and surgical larynx preservation options.

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Phase I/II Trial of Concurrent Use of S-1 and Radiation Therapy for T2 Glottic Cancer

Cited by 33 publications

References 13 publications

Phase II Study of Concurrent Chemoradiotherapy with S-1 in Patients with Stage II (T2N0M0) Squamous Cell Carcinoma of the Pharynx or Larynx

Phase II Study of Concurrent Chemoradiotherapy with S-1 in Patients with Stage II (T2N0M0) Squamous Cell Carcinoma of the Pharynx or Larynx

Phase I Study of Oral S-1 and Concurrent Radiotherapy in Patients with Head and Neck Cancer

Clinical Outcomes of 849 Laryngeal Cancers Treated in the Past 40 Years: Are We Succeeding?

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