Phase I and initial Phase II results from a trial investigating weekly docetaxel and carboplatin given neoadjuvantly and then concurrently with concomitant boost radiotherapy for locally advanced squamous cell carcinoma of the head and neck

David L. Schwartz, R. Bruce Montgomery, Bevan Yueh, Michael Donahue, Yoshimi Anzai, Raylene Canby, Raelene Buelna, Leslie Anderson, Charles Boyd, Janice Hutson, Kathryn Keegan

Research output: Contribution to journalArticle

18 Citations (Scopus)

Abstract

BACKGROUND. The current Phase I/II study assessed induction docetaxel/carboplatin given weekly for 4 weeks, followed by weekly docetaxel/carboplatin and concomitant boost radiotherapy (CB-XRT) for locally advanced head and neck squamous cell carcinoma. METHODS. Twenty patients with Stage III or IV (M0) disease of the oropharynx, supraglottic larynx, or hypopharynx were enrolled. Patients initially received docetaxel 20 mg/m 2 and carboplatin area under the curve (AUC) 2 weekly × 4. Patients with stable (SD) or responding disease subsequently received dose-escalated docetaxel (10-20 mg/m2 in sequential patient cohorts) and carboplatin AUC 1 weekly × 5 with CB-XRT (1.8 gray [Gy] every day × 15 days, followed by 1.8/1.5 Gy twice per day × 13 days). RESULTS. All patients were evaluable, and 15 patients (5 patients with Stage III disease, 10 patients with Stage IV disease) completed all planned therapy. The target docetaxel dose level of 20 mg/m2 weekly with radiotherapy was achieved with no dose-limiting toxicities. The most frequent maximum toxicities during chemoradiotherapy were Grade 3 mucositis, dysphagia, and/or pain. Primary site responses after induction included 4 patients with partial responses, 11 patients with SD, and 5 patients with disease progression. Fifteen patients (75%) continued to receive chemoradiotherapy, with 14 patients attaining a complete response (CR). Overall, a clinicopathologic neck CR after chemoradiotherapy was achieved in 9 of 10 patients. One patient had persistent primary disease and underwent salvage surgery, whereas another died of unrelated causes before neck assessment. Thirteen patients remain free of any disease event, with a median follow-up of 15 months (range, 3-29 months). CONCLUSIONS. This regimen was feasible, safe, and particularly well tolerated. Early Phase II outcomes revealed promising activity in patients completing all treatment. Initial induction response results suggested that further investigation of this regimen with more aggressive induction therapy is warranted.

Original languageEnglish (US)
Pages (from-to)2534-2543
Number of pages10
JournalCancer
Volume103
Issue number12
DOIs
StatePublished - Jun 15 2005

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docetaxel
Carboplatin
Radiotherapy
Chemoradiotherapy
Carcinoma, squamous cell of head and neck

Keywords

  • Altered fractionation
  • Combined modality therapy
  • Concomitant boost
  • Docetaxel
  • Head and neck carcinoma
  • Radiotherapy

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

Phase I and initial Phase II results from a trial investigating weekly docetaxel and carboplatin given neoadjuvantly and then concurrently with concomitant boost radiotherapy for locally advanced squamous cell carcinoma of the head and neck. / Schwartz, David L.; Montgomery, R. Bruce; Yueh, Bevan; Donahue, Michael; Anzai, Yoshimi; Canby, Raylene; Buelna, Raelene; Anderson, Leslie; Boyd, Charles; Hutson, Janice; Keegan, Kathryn.

In: Cancer, Vol. 103, No. 12, 15.06.2005, p. 2534-2543.

Research output: Contribution to journalArticle

Schwartz, David L. ; Montgomery, R. Bruce ; Yueh, Bevan ; Donahue, Michael ; Anzai, Yoshimi ; Canby, Raylene ; Buelna, Raelene ; Anderson, Leslie ; Boyd, Charles ; Hutson, Janice ; Keegan, Kathryn. / Phase I and initial Phase II results from a trial investigating weekly docetaxel and carboplatin given neoadjuvantly and then concurrently with concomitant boost radiotherapy for locally advanced squamous cell carcinoma of the head and neck. In: Cancer. 2005 ; Vol. 103, No. 12. pp. 2534-2543.
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abstract = "BACKGROUND. The current Phase I/II study assessed induction docetaxel/carboplatin given weekly for 4 weeks, followed by weekly docetaxel/carboplatin and concomitant boost radiotherapy (CB-XRT) for locally advanced head and neck squamous cell carcinoma. METHODS. Twenty patients with Stage III or IV (M0) disease of the oropharynx, supraglottic larynx, or hypopharynx were enrolled. Patients initially received docetaxel 20 mg/m 2 and carboplatin area under the curve (AUC) 2 weekly × 4. Patients with stable (SD) or responding disease subsequently received dose-escalated docetaxel (10-20 mg/m2 in sequential patient cohorts) and carboplatin AUC 1 weekly × 5 with CB-XRT (1.8 gray [Gy] every day × 15 days, followed by 1.8/1.5 Gy twice per day × 13 days). RESULTS. All patients were evaluable, and 15 patients (5 patients with Stage III disease, 10 patients with Stage IV disease) completed all planned therapy. The target docetaxel dose level of 20 mg/m2 weekly with radiotherapy was achieved with no dose-limiting toxicities. The most frequent maximum toxicities during chemoradiotherapy were Grade 3 mucositis, dysphagia, and/or pain. Primary site responses after induction included 4 patients with partial responses, 11 patients with SD, and 5 patients with disease progression. Fifteen patients (75{\%}) continued to receive chemoradiotherapy, with 14 patients attaining a complete response (CR). Overall, a clinicopathologic neck CR after chemoradiotherapy was achieved in 9 of 10 patients. One patient had persistent primary disease and underwent salvage surgery, whereas another died of unrelated causes before neck assessment. Thirteen patients remain free of any disease event, with a median follow-up of 15 months (range, 3-29 months). CONCLUSIONS. This regimen was feasible, safe, and particularly well tolerated. Early Phase II outcomes revealed promising activity in patients completing all treatment. Initial induction response results suggested that further investigation of this regimen with more aggressive induction therapy is warranted.",
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T1 - Phase I and initial Phase II results from a trial investigating weekly docetaxel and carboplatin given neoadjuvantly and then concurrently with concomitant boost radiotherapy for locally advanced squamous cell carcinoma of the head and neck

AU - Schwartz, David L.

AU - Montgomery, R. Bruce

AU - Yueh, Bevan

AU - Donahue, Michael

AU - Anzai, Yoshimi

AU - Canby, Raylene

AU - Buelna, Raelene

AU - Anderson, Leslie

AU - Boyd, Charles

AU - Hutson, Janice

AU - Keegan, Kathryn

PY - 2005/6/15

Y1 - 2005/6/15

N2 - BACKGROUND. The current Phase I/II study assessed induction docetaxel/carboplatin given weekly for 4 weeks, followed by weekly docetaxel/carboplatin and concomitant boost radiotherapy (CB-XRT) for locally advanced head and neck squamous cell carcinoma. METHODS. Twenty patients with Stage III or IV (M0) disease of the oropharynx, supraglottic larynx, or hypopharynx were enrolled. Patients initially received docetaxel 20 mg/m 2 and carboplatin area under the curve (AUC) 2 weekly × 4. Patients with stable (SD) or responding disease subsequently received dose-escalated docetaxel (10-20 mg/m2 in sequential patient cohorts) and carboplatin AUC 1 weekly × 5 with CB-XRT (1.8 gray [Gy] every day × 15 days, followed by 1.8/1.5 Gy twice per day × 13 days). RESULTS. All patients were evaluable, and 15 patients (5 patients with Stage III disease, 10 patients with Stage IV disease) completed all planned therapy. The target docetaxel dose level of 20 mg/m2 weekly with radiotherapy was achieved with no dose-limiting toxicities. The most frequent maximum toxicities during chemoradiotherapy were Grade 3 mucositis, dysphagia, and/or pain. Primary site responses after induction included 4 patients with partial responses, 11 patients with SD, and 5 patients with disease progression. Fifteen patients (75%) continued to receive chemoradiotherapy, with 14 patients attaining a complete response (CR). Overall, a clinicopathologic neck CR after chemoradiotherapy was achieved in 9 of 10 patients. One patient had persistent primary disease and underwent salvage surgery, whereas another died of unrelated causes before neck assessment. Thirteen patients remain free of any disease event, with a median follow-up of 15 months (range, 3-29 months). CONCLUSIONS. This regimen was feasible, safe, and particularly well tolerated. Early Phase II outcomes revealed promising activity in patients completing all treatment. Initial induction response results suggested that further investigation of this regimen with more aggressive induction therapy is warranted.

AB - BACKGROUND. The current Phase I/II study assessed induction docetaxel/carboplatin given weekly for 4 weeks, followed by weekly docetaxel/carboplatin and concomitant boost radiotherapy (CB-XRT) for locally advanced head and neck squamous cell carcinoma. METHODS. Twenty patients with Stage III or IV (M0) disease of the oropharynx, supraglottic larynx, or hypopharynx were enrolled. Patients initially received docetaxel 20 mg/m 2 and carboplatin area under the curve (AUC) 2 weekly × 4. Patients with stable (SD) or responding disease subsequently received dose-escalated docetaxel (10-20 mg/m2 in sequential patient cohorts) and carboplatin AUC 1 weekly × 5 with CB-XRT (1.8 gray [Gy] every day × 15 days, followed by 1.8/1.5 Gy twice per day × 13 days). RESULTS. All patients were evaluable, and 15 patients (5 patients with Stage III disease, 10 patients with Stage IV disease) completed all planned therapy. The target docetaxel dose level of 20 mg/m2 weekly with radiotherapy was achieved with no dose-limiting toxicities. The most frequent maximum toxicities during chemoradiotherapy were Grade 3 mucositis, dysphagia, and/or pain. Primary site responses after induction included 4 patients with partial responses, 11 patients with SD, and 5 patients with disease progression. Fifteen patients (75%) continued to receive chemoradiotherapy, with 14 patients attaining a complete response (CR). Overall, a clinicopathologic neck CR after chemoradiotherapy was achieved in 9 of 10 patients. One patient had persistent primary disease and underwent salvage surgery, whereas another died of unrelated causes before neck assessment. Thirteen patients remain free of any disease event, with a median follow-up of 15 months (range, 3-29 months). CONCLUSIONS. This regimen was feasible, safe, and particularly well tolerated. Early Phase II outcomes revealed promising activity in patients completing all treatment. Initial induction response results suggested that further investigation of this regimen with more aggressive induction therapy is warranted.

KW - Altered fractionation

KW - Combined modality therapy

KW - Concomitant boost

KW - Docetaxel

KW - Head and neck carcinoma

KW - Radiotherapy

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