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 Oncology Group Study E2399

2007 ◽  
Vol 25 (25) ◽  
pp. 3971-3977 ◽  
Author(s):  
Anthony J. Cmelak ◽  
Sigui Li ◽  
Meredith A. Goldwasser ◽  
Barbara Murphy ◽  
Michael Cannon ◽  
...  
Keyword(s):  
Induction Chemotherapy ◽  
Phase Ii ◽  
Organ Preservation ◽  
Concurrent Chemoradiotherapy ◽  
Radiation Treatment ◽  
Salvage Surgery ◽  
Eastern Cooperative Oncology Group ◽  
Primary Site ◽  
Stage Iii ◽  
Time Curve

PurposeTaxane-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 MethodsEligibility 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/m2and carboplatin area under the concentration-time curve (AUC) 6 for two cycles every 21 days followed by concurrent paclitaxel 30 mg/m2every 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).ResultsOne 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).ConclusionA 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.

Locally advanced resectable larynx (L) or oropharynx (OP) cancer: Updated results of organ preservation trial ECOG 2399

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 5527-5527 ◽  
Author(s):  
A. J. Cmelak ◽  
S. Li ◽  
B. Murphy ◽  
B. Burkey ◽  
G. L. Adams ◽  
...  
Keyword(s):  
Induction Chemotherapy ◽  
Organ Preservation ◽  
Radiation Treatment ◽  
Salvage Surgery ◽  
Locally Advanced ◽  
Institutional Setting ◽  
Free Survival ◽  
Grade 5 ◽  
Epoetin Alpha ◽  
One Year

5527 Background: Taxane-based concurrent chemoradiation (CCR) for head and neck cancers has proven feasible and has a favorable toxicity profile compared to concurrent cisplatin and radiation. This phase II multi-institutional trial evaluates taxane-based induction chemotherapy followed by CCR for organ preservation in resectable Stage III/IV L and OP patients. Methods: Eligibility: Resectable stage T2N+, or T3-T4N0–3M0 biopsy-proven squamous Ca, age ≥18, PS 0–2, good organ function, and no prior chemotherapy or radiation. Treatment: induction paclitaxel (P) 175 mg/m2 and carboplatin (C) AUC 6 for 2 cycles q21d followed by concurrent P 30 mg/m2 q7d with 70 Gy if no evidence of progression. Weekly epoetin alpha 40kU was used if Hgb ≤15 (male) or ≤14 (female). The primary endpoint is organ preservation (freedom from salvage surgery with preserved speech and swallowing). Results: 105/111 pts (69 OP, 36 larynx) were eligible. Median FU is 33 months. No grade 5 toxicities occurred. 94% received full dose RT and 91% received ≥5 cycles of concurrent paclitaxel. At one year post-treatment, 13 (12%) patients required salvage surgery at the primary site (7-L, 6-OP), and 6 pts (6%) progressed and died (3-L, 3-OP). 1 pt (1%) died without progression and 85 pts (81%) are alive without progression (25-L, 60-OP). 12 pts (10%) have developed distant mets (6-L, 6-OP). 1-yr and 2-yr PFS for all pts is 77% and 64%. 12/69 OP and 9/36 L pts have died of disease. 1-yr event-free survival (EFS = no salvage surgery, recurrence or death) is 72% (77%-OP, 64%-L), and 2-yr EFS is 57% (68%-OP, 34%-L) (p = 0.02). 1-yr OS is 93%, 2-yr OS is 74% (OP vs. L p = 0.11). Conclusions: This regimen is well tolerated and is feasible in a multi-institutional setting. EFS with this regimen is lower than expected in larynx patients. The benefit of induction chemotherapy in this setting remains unproven but does not preclude CCR delivery. Funded, in part, by Bristol-Myers Squibb. [Table: see text]

Organ Preservation for Advanced Resectable Cancer of the Base of Tongue and Hypopharynx: A Southwest Oncology Group Trial

2005 ◽  
Vol 23 (1) ◽  
pp. 88-95 ◽  
Author(s):  
Susan G. Urba ◽  
James Moon ◽  
P.G. Shankar Giri ◽  
David J. Adelstein ◽  
Ehab Hanna ◽  
...  
Keyword(s):  
Induction Chemotherapy ◽  
Organ Preservation ◽  
Salvage Surgery ◽  
Hypopharyngeal Cancer ◽  
Primary Site ◽  
Oncology Group ◽  
Definitive Chemoradiotherapy ◽  
Primary Tumor Site ◽  
Southwest Oncology Group ◽  
Base Of Tongue

Purpose The Southwest Oncology Group designed a phase II trial for patients with base of tongue or hypopharyngeal cancer to evaluate the complete histologic response rate at the primary site after induction chemotherapy followed by chemoradiotherapy for responders. Secondary end points were the rate of organ preservation and the need for salvage surgery. Patients and Methods Fifty-nine eligible patients were enrolled; 37 had base of tongue cancer, and 22 had hypopharynx cancer. Forty-two percent had stage III disease, and 58% had stage IV disease. Induction chemotherapy was two cycles of cisplatin 100 mg/m2 and fluorouracil 1,000 mg/m2/d for 5 days. Patients who had a greater than 50% response at the primary site were treated with radiation 72Gy and concurrent cisplatin 100 mg/m2 for three cycles. Patients with less than partial response at the primary had immediate salvage surgery. Results Forty-five patients (76%) had a greater than 50% response at the primary after induction chemotherapy; 43 went on to receive definitive chemoradiotherapy. Thirty-two patients (54%) achieved a histologic complete response at the primary site, and an additional nine patients had a complete clinical response, but biopsy was not done. Seventy-five percent of patients did not require surgery at the primary tumor site. The 3-year overall survival was 64%. The 3-year progression-free survival with organ preservation was 52%. Conclusion Patients with base of tongue or hypopharyngeal cancer treated with this regimen of induction chemotherapy followed by definitive chemoradiotherapy have a good rate of organ preservation without compromise of survival.

Phase II organ-preservation trial: Concurrent cisplatin and radiotherapy for advanced laryngeal cancer after response to docetaxel, cisplatin, and 5-fluorouracil-based induction chemotherapy

Head & Neck ◽  
2016 ◽  
Vol 39 (2) ◽  
pp. 227-233 ◽  
Author(s):  
Aron Popovtzer ◽  
Hanna Burnstein ◽  
Salomon Stemmer ◽  
Dror Limon ◽  
Ohad Hili ◽  
...  
Keyword(s):  
Induction Chemotherapy ◽  
Phase Ii ◽  
Laryngeal Cancer ◽  
Organ Preservation

P-5 A phase II trial of paclitaxel carboplatin and gemcitabine as induction chemotherapy for stage III NSCLC

Lung Cancer ◽  
2003 ◽  
Vol 41 ◽  
pp. S92
Author(s):  
Carmelo Giannitto Giorgio ◽  
Salvino Saita ◽  
Franco Marletta ◽  
Stefano Cordio ◽  
Dario Giuffrida ◽  
...  
Keyword(s):  
Induction Chemotherapy ◽  
Phase Ii ◽  
Phase Ii Trial ◽  
Stage Iii ◽  
Stage Iii Nsclc

Debulking Surgery Plus Radiation: Treatment Choice for Unresectable Stage III Thymic Carcinoma

2019 ◽  
Vol 68 (05) ◽  
pp. 440-445
Author(s):  
Yirui Zhai ◽  
Zhouguang Hui ◽  
Yushun Gao ◽  
Jun Liang ◽  
Zongmei Zhou ◽  
...  
Keyword(s):  
Thymic Carcinoma ◽  
Group Performance ◽  
Radiation Treatment ◽  
Postoperative Radiotherapy ◽  
Performance Status ◽  
Treatment Options ◽  
Eastern Cooperative Oncology Group ◽  
Stage Iii ◽  
Debulking Surgery ◽  
Masaoka Stage

Background Total resection may not be achieved in patients with thymic carcinoma, particularly those with Masaoka stage III disease. Debulking surgery plus postoperative radiotherapy and radiation alone are treatment options for such patients. We aimed to compare the overall survival (OS) between patients with thymic carcinoma who underwent debulking surgery plus postoperative radiotherapy and those who underwent radiation alone. Methods This was a single-center retrospective study of patients histologically diagnosed as having Masaoka stage III thymic carcinoma between January 1980 and January 2010. Patients were classified into the following groups according to treatments received: debulking surgery plus radiotherapy (group A) and radiotherapy alone (group B). Data on demographics, histology, invasion, radiotherapy, chemotherapy, and survival were collected. Survival time was calculated and compared between the groups using the Kaplan–Meier method. Toxicities were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0. Results Of the 47 enrolled patients, 26 and 21 patients were categorized into groups A and B, respectively. There are no significant differences in the Eastern Cooperative Oncology Group performance status score, histological type, great vessel invasion, and chemotherapy proportion between the groups. The median radiation dose was 60 Gy in both groups. The 5-year OS rates were 54.4 and 0% in groups A and B, respectively (p = 0.019). No operation-induced mortality was recorded. Conclusion For patients with unresectable Masaoka stage III disease, debulking surgery with radiotherapy is preferred, as this was proven to be more efficient than the radiation-alone procedure.

Sign in / Sign up

Export Citation Format

Share Document