Abstract
Purpose: Taxane-based concurrent chemoradiotherapy (CCR) for head and neck cancers has proven to have a favorable toxicity profile compared with cisplatin and radiation. This phase II multi-institutional trial evaluates taxane-based induction chemotherapy followed by CCR for organ preservation in resectable stage III/IVA and IVB larynx and oropharynx (OP) cancer patients. Patients and Methods: Eligibility required resectable stage T2N + , or T3-T4N0-3M0 biopsy-proven squamous carcinoma, age at least 18 years, PS 0 to 2, good organ function, and no prior chemotherapy or radiation. Treatment was induction paclitaxel 175 mg/m2 and carboplatin area under the concentration-time curve (AUC) 6 for two cycles every 21 days followed by concurrent paclitaxel 30 mg/m2 every 7 days with 70 Gy if no evidence of tumor progression. Weekly erythropoietin alpha 40 kU was used for suboptimal hemoglobin (<14 gm/dL men, <13 gm/dL women). The primary end point was organ preservation (freedom from primary site salvage surgery or primary tumor recurrence). Results: One hundred five of 111 patients (36 larynx, 69 OP) were eligible. Median follow-up was 36.7 months. Ninety-four percent received full-dose radiotherapy and 91 % received at least five cycles of concurrent paclitaxel. No patient progressed while receiving chemotherapy. Organ preservation was 81 % at 2 years after completion of therapy (larynx 74%, OP 84%). Thirteen patients required primary-site salvage surgery (seven larynx, six OP), and six of these have progressed and died (three larynx, three OP). Thirteen patients developed distant metastases (seven larynx, six OP; P = .02) and 10 of 36 larynx and 11 of 69 OP patients have died as a result of their disease. Two-year survival is 76% (63% larynx v 83% OP). Conclusion: A high organ preservation rate was obtained with this regimen for OP but not for larynx patients. Toxicity was low, and induction chemotherapy did not preclude delivery of concurrent chemoradiotherapy.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 3971-3977 |
| Number of pages | 7 |
| Journal | Journal of Clinical Oncology |
| Volume | 25 |
| Issue number | 25 |
| DOIs | |
| State | Published - Sep 1 2007 |
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ASJC Scopus subject areas
- Cancer Research
- Oncology
- Medicine(all)
Cite this
Phase II trial of chemoradiation for organ preservation in resectable stage III or IV squamous cell carcinomas of the larynx or oropharynx : Results of Eastern Cooperative Oncologv Group Study E2399. / Cmelak, Anthony J.; Li, Sigui; Goldwasser, Meredith A.; Murphy, Barbara; Cannon, Michael; Pinto, Harlan; Rosenthal, David I.; Gillison, Maura; Forastiere, Arlene A.
In: Journal of Clinical Oncology, Vol. 25, No. 25, 01.09.2007, p. 3971-3977.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Phase II trial of chemoradiation for organ preservation in resectable stage III or IV squamous cell carcinomas of the larynx or oropharynx
T2 - Results of Eastern Cooperative Oncologv Group Study E2399
AU - Cmelak, Anthony J.
AU - Li, Sigui
AU - Goldwasser, Meredith A.
AU - Murphy, Barbara
AU - Cannon, Michael
AU - Pinto, Harlan
AU - Rosenthal, David I.
AU - Gillison, Maura
AU - Forastiere, Arlene A.
PY - 2007/9/1
Y1 - 2007/9/1
N2 - Purpose: Taxane-based concurrent chemoradiotherapy (CCR) for head and neck cancers has proven to have a favorable toxicity profile compared with cisplatin and radiation. This phase II multi-institutional trial evaluates taxane-based induction chemotherapy followed by CCR for organ preservation in resectable stage III/IVA and IVB larynx and oropharynx (OP) cancer patients. Patients and Methods: Eligibility required resectable stage T2N + , or T3-T4N0-3M0 biopsy-proven squamous carcinoma, age at least 18 years, PS 0 to 2, good organ function, and no prior chemotherapy or radiation. Treatment was induction paclitaxel 175 mg/m2 and carboplatin area under the concentration-time curve (AUC) 6 for two cycles every 21 days followed by concurrent paclitaxel 30 mg/m2 every 7 days with 70 Gy if no evidence of tumor progression. Weekly erythropoietin alpha 40 kU was used for suboptimal hemoglobin (<14 gm/dL men, <13 gm/dL women). The primary end point was organ preservation (freedom from primary site salvage surgery or primary tumor recurrence). Results: One hundred five of 111 patients (36 larynx, 69 OP) were eligible. Median follow-up was 36.7 months. Ninety-four percent received full-dose radiotherapy and 91 % received at least five cycles of concurrent paclitaxel. No patient progressed while receiving chemotherapy. Organ preservation was 81 % at 2 years after completion of therapy (larynx 74%, OP 84%). Thirteen patients required primary-site salvage surgery (seven larynx, six OP), and six of these have progressed and died (three larynx, three OP). Thirteen patients developed distant metastases (seven larynx, six OP; P = .02) and 10 of 36 larynx and 11 of 69 OP patients have died as a result of their disease. Two-year survival is 76% (63% larynx v 83% OP). Conclusion: A high organ preservation rate was obtained with this regimen for OP but not for larynx patients. Toxicity was low, and induction chemotherapy did not preclude delivery of concurrent chemoradiotherapy.
AB - Purpose: Taxane-based concurrent chemoradiotherapy (CCR) for head and neck cancers has proven to have a favorable toxicity profile compared with cisplatin and radiation. This phase II multi-institutional trial evaluates taxane-based induction chemotherapy followed by CCR for organ preservation in resectable stage III/IVA and IVB larynx and oropharynx (OP) cancer patients. Patients and Methods: Eligibility required resectable stage T2N + , or T3-T4N0-3M0 biopsy-proven squamous carcinoma, age at least 18 years, PS 0 to 2, good organ function, and no prior chemotherapy or radiation. Treatment was induction paclitaxel 175 mg/m2 and carboplatin area under the concentration-time curve (AUC) 6 for two cycles every 21 days followed by concurrent paclitaxel 30 mg/m2 every 7 days with 70 Gy if no evidence of tumor progression. Weekly erythropoietin alpha 40 kU was used for suboptimal hemoglobin (<14 gm/dL men, <13 gm/dL women). The primary end point was organ preservation (freedom from primary site salvage surgery or primary tumor recurrence). Results: One hundred five of 111 patients (36 larynx, 69 OP) were eligible. Median follow-up was 36.7 months. Ninety-four percent received full-dose radiotherapy and 91 % received at least five cycles of concurrent paclitaxel. No patient progressed while receiving chemotherapy. Organ preservation was 81 % at 2 years after completion of therapy (larynx 74%, OP 84%). Thirteen patients required primary-site salvage surgery (seven larynx, six OP), and six of these have progressed and died (three larynx, three OP). Thirteen patients developed distant metastases (seven larynx, six OP; P = .02) and 10 of 36 larynx and 11 of 69 OP patients have died as a result of their disease. Two-year survival is 76% (63% larynx v 83% OP). Conclusion: A high organ preservation rate was obtained with this regimen for OP but not for larynx patients. Toxicity was low, and induction chemotherapy did not preclude delivery of concurrent chemoradiotherapy.
UR - http://www.scopus.com/inward/record.url?scp=34548541943&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=34548541943&partnerID=8YFLogxK
U2 - 10.1200/JCO.2007.10.8951
DO - 10.1200/JCO.2007.10.8951
M3 - Article
C2 - 17761982
AN - SCOPUS:34548541943
VL - 25
SP - 3971
EP - 3977
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
SN - 0732-183X
IS - 25
ER -