scholarly journals Proton Therapy for Head and Neck Cancer: A 12-Year, Single-Institution Experience

2021 ◽  
Vol 8 (1) ◽  
pp. 108-118
Author(s):  
G. Brandon Gunn ◽  
Adam S. Garden ◽  
Rong Ye ◽  
Noveen Ausat ◽  
Kristina R. Dahlstrom ◽  
...  
Keyword(s):  
Overall Survival ◽  
Head And Neck Cancer ◽  
Proton Therapy ◽  
Disease Free Survival ◽  
Free Survival ◽  
Regional Control ◽  
Grade 5 ◽  
Grade 3 ◽  
Local Regional Control ◽  
Disease Free

Abstract Purpose To characterize our experience and the disease control and toxicity of proton therapy (PT) for patients with head and neck cancer (HNC). Patients and Methods Clinical outcomes for patients with HNC treated with PT at our institution were prospectively collected in 2 institutional review board–approved prospective studies. Descriptive statistics were used to summarize patient characteristics and outcomes. Overall survival, local-regional control, and disease-free survival were estimated by the Kaplan-Meier method. Treatment-related toxicities were recorded according to the Common Terminology Criteria for Adverse Events (version 4.03) scale. Results The cohort consisted of 573 patients treated from February 2006 to June 2018. Median patient age was 61 years. Oropharynx (33.3%; n = 191), paranasal sinus (11%; n = 63), and periorbital tissues (11%; n = 62) were the most common primary sites. Patients with T3/T4 or recurrent disease comprised 46% (n = 262) of the cohort. The intent of PT was definitive in 53% (n = 303), postoperative in 37% (n = 211), and reirradiation in 10% (n = 59). Median dose was 66 Gy (radiobiological equivalent). Regarding systemic therapy, 43% had received concurrent (n = 244), 3% induction (n = 19), and 15% (n = 86) had both. At a median follow-up of 2.4 years, 88 patients (15%) had died and 127 (22%) developed disease recurrence. The overall survival, local-regional control, and disease-free survival at 2 and 5 years were, respectively, 87% and 75%, 87% and 78%, and 74% and 63%. Maximum toxicity (acute or late) was grade 3 in 293 patients (51%), grade 2 in 234 patients (41%), and grade 1 in 31 patients (5%). There were 381 acute grade 3 and 190 late grade 3 unique toxicities across 212 (37%) and 150 (26%) patients, respectively. There were 3 late-grade 4 events across 2 patients (0.3%), 2 (0.3%) acute-grade 5, and no (0%) late-grade 5 events. Conclusions The overall results from this prospective study of our initial decade of experience with PT for HNC show favorable disease control and toxicity outcomes in a multidisease-site cohort and provide a reference benchmark for future comparison and study.

NRG Oncology RTOG 0415: A randomized phase III non-inferiority study comparing two fractionation schedules in patients with low-risk prostate cancer.

2016 ◽  
Vol 34 (2_suppl) ◽  
pp. 1-1 ◽  
Author(s):  
W. Robert Lee ◽  
James J. Dignam ◽  
Mahul Amin ◽  
Deborah Bruner ◽  
Daniel Low ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Overall Survival ◽  
Biochemical Recurrence ◽  
Disease Free Survival ◽  
Low Risk ◽  
Free Survival ◽  
Risk Prostate Cancer ◽  
Low Risk Prostate Cancer ◽  
Grade 3 ◽  
Disease Free

1 Background: To determine whether the efficacy of a hypofractionated (H) schedule is no worse than a conventional (C) schedule in men with low-risk prostate cancer. Methods: From April 2006 to December 2009, one thousand one hundred fifteen men with low-risk prostate cancer (clinical stage T1-2a, Gleason ≤ 6, PSA < 10) were randomly assigned 1:1 to a conventional (C) schedule (73.8 Gy in 41 fractions over 8.2 weeks) or to a hypofractionated (H) schedule (70 Gy in 28 fractions over 5.6 weeks). The trial was designed to establish with 90% power and alpha = 0.05 that (H) results in 5-year disease-free survival (DFS) that is not lower than (C) by more than 7% (hazard ratio (HR) < 1.52). Secondary endpoints include freedom from biochemical recurrence (FFBR) and overall survival. At the third planned interim analysis (July 2015), the NRG Oncology Data Monitoring Committee recommended that the results of the trial be reported. Results: One thousand one hundred and one protocol eligible men were randomized: 547 to C and 554 to H. Median follow-up is 5.9 years. Baseline characteristics are not different according to treatment arm. At the time of analysis 185 DFS events have been observed; 99 in the C arm and 86 in the H arm. The estimated 7-year disease-free survival is 75.6% (95% CI 70.3, 80.1) in the C arm and 81.8% (77.5, 85.3) in the H arm. The DFS HR (C/H) is 0.85 (0.64, 1.14). Comparison of biochemical recurrence (HR = 0.77, (0.51, 1.17)) and overall survival (HR = 0.95, (0.65, 1.41)) also met protocol non-inferiority criteria. Grade ≥ 3 GI toxicity is 3.0% (C) vs. 4.6% (H), Relative risk (RR) for H vs. C 1.53, (95% CI 0.86, 2.83); grade ≥ 3 GU toxicity is 4.5% (C) vs. 6.4% (H), RR = 1.43 (0.86,2.37). Conclusions: In men with low-risk prostate cancer, 70 Gy in 28 fractions over 5.6 weeks is non-inferior to 73.8 Gy in 41 fractions over 8.2 weeks. Clinical trial information: NCT00331773.

scholarly journals Passively Scattered Proton Therapy for Nonmelanoma Skin Cancer with Clinical Perineural Invasion

2021 ◽  
Vol 8 (1) ◽  
pp. 285-293
Author(s):  
Curtis M. Bryant ◽  
Roi Dagan ◽  
Adam L. Holtzman ◽  
Rui Fernandes ◽  
Anthony Bunnell ◽  
...  
Keyword(s):  
Skin Cancer ◽  
Proton Therapy ◽  
Perineural Invasion ◽  
Survival Rates ◽  
Late Toxicity ◽  
Nonmelanoma Skin Cancer ◽  
Free Survival ◽  
Regional Control ◽  
Grade 3 ◽  
Local Regional Control

Abstract Purpose To report our experience with the delivery of passively scattered proton therapy in the management of nonmelanoma skin cancers with clinical perineural invasion. Materials and Methods We reviewed the medical records of patients who received definitive or postoperative proton therapy for nonmelanoma skin cancer with clinical perineural invasion at our institution and updated patient follow-up when possible. All patients were treated with curative intent with or without the delivery of concurrent systemic therapy. We report disease control rates and the rates of late toxicity among this cohort. Results Twenty-six patients treated between 2008 and 2017 were included in the analysis. Following proton therapy, the 3-year overall, cause-specific, and disease-free survival rates were 59%, 73%, and 60%, respectively. The 3-year local control, local regional control, and distant metastasis-free survival rates were 80%, 65%, and 96%, respectively. On univariate analysis, surgical resection before radiation therapy significantly improved local regional control rates at 3 years (55% versus 86%; P = .04). Grade 3+ late toxicities occurred in 13 patients (50%) and the most common toxicities included grade 3+ keratitis of the ipsilateral eye, which occurred in 4 patients (15%) and grade 3+ brain necrosis in 4 patients (15%). Conclusion Proton therapy is effective in the management of nonmelanoma skin cancer with clinical perineural invasion. Although disease control and complication rates compare favorably to those previously published for photon-based radiation therapy, the risk for late toxicity is significant and patients should be appropriately counseled.

Treatment of Relapsed or Refractory Non-Hodgkin’s Lymphoma (NHL) or Hodgkin’s Disease (HD) with High-Dose Chemotherapy and Autologous Hematopoietic Stem Cell Transplantation (HSCT) Using a Novel Mitoxantrone-Containing Preparative Regimen.

Blood ◽  
2006 ◽  
Vol 108 (11) ◽  
pp. 5264-5264
Author(s):  
Leslie Andritsos ◽  
Wendy Suhre ◽  
Mark Nahirny ◽  
Ellen Chase ◽  
Michael Carroll ◽  
...  
Keyword(s):  
Overall Survival ◽  
Median Time ◽  
Cardiac Toxicity ◽  
Disease Free Survival ◽  
High Dose Chemotherapy ◽  
High Dose ◽  
Free Survival ◽  
Preparative Regimen ◽  
Grade 3 ◽  
Disease Free

Abstract High-dose chemotherapy with autologous HSCT is potentially curative in patients (pts) with relapsed or refractory lymphoma. However, the optimal pre-HSCT conditioning regimen is not known. Mitoxantrone, an antineoplastic agent that inhibits DNA synthesis by inhibition of topoisomerase II and by intercalation into the DNA molecule, has shown activity in several hematological malignancies, including NHL and HD. Recent evidence suggests that mitoxantrone may be more cardiotoxic than previously recognized. We evaluated a novel mitoxantrone-containing preparative regimen for autologous HSCT in pts with relapsed or refractory NHL or HD. Between 1989 and 1996, 59 pts (31 NHL, 28 HD) with chemotherapy refractory or relapsed lymphoma were enrolled. The median age was 36 yr (range, 10–60); 38 pts were male, and 21 were female. Cohorts of pts received escalating doses of mitoxantrone (24–60 mg/m2) on day -8, etoposide 1800 mg/m2 on day -8, cyclophosphamide 1800 mg/m2 on days -7 through -3, and carmustine 300 mg/m2 on day -3. Autologous stem cells were infused on day 0. G-CSF was begun day +3. Patients with areas of bulky disease pre-transplant underwent consolidative involved field radiotherapy, but no earlier than day +14. Results: Patients received mitoxantrone according to the following dose escalation: 24 mg/m2 (n=3), 30 mg/m2 (n=1), 36 mg/m2 (n=3), 42 mg/m2 (n=3), 48 mg/m2 (n=48), 54 mg/m2 (n=1). Median time to neutrophil engraftment was 13 days (range, 8–60 days) and median time to platelet engraftment was 17 days (range, 5–51 days). Non-hematologic toxicities were measured according to the NCI CTCAE Version 3.0. Toxicities greater than grade 2 included mucositis in 35 patients (24 grade 3, 11 grade 4), nausea and vomiting in 9 (6 grade 3, 3 grade 4), diarrhea in 5 (all grade 3), hepatotoxicity in 5 (all grade 3), and nephrotoxicity in 14 (12 grade 3, 2 grade 4). The dose limiting toxicity for mitoxantrone was cardiac toxicity, and the maximum tolerated dose was 48 mg/m2. Early cardiac toxicity was observed in 2 patients: one was withdrawn from the clinical trial before HSCT due to cardiotoxicity, and one patient died on day +8 of cardiotoxicity. Late (≥ 100 days after HSCT) nonfatal cardiac toxicity included cardiomyopathy (n=1), and cardiac tamponade (n=1). For all patients, the 5-year overall survival post HSCT was 51%, and 5-year disease free survival was 37%. Median time to relapse was 24 mo (range, 3.6–71.9 mo) after HSCT. For the 31 patients with NHL, the 5-year overall survival was 48% and 5-year disease-free survival was 35%. For the 28 patients with HD, the 5-year overall survival was 50% and the 5-year disease-free survival was 39%. Conclusion: The addition of mitoxantrone to standard preparative regimens may improve outcomes in patients with relapsed or refractory lymphoma, however further investigations of this agent in pre-HSCT conditioning regimens must carefully consider strategies that minimize the risks of cardiac toxicity.

Response to Paclitaxel, Topotecan, and Topotecan-Cyclophosphamide in Children With Untreated Disseminated Neuroblastoma Treated in an Upfront Phase II Investigational Window: A Pediatric Oncology Group Study

2004 ◽  
Vol 22 (20) ◽  
pp. 4119-4126 ◽  
Author(s):  
Cynthia S. Kretschmar ◽  
Morris Kletzel ◽  
Kevin Murray ◽  
Paul Thorner ◽  
Vijay Joshi ◽  
...  
Keyword(s):  
Bone Marrow ◽  
Overall Survival ◽  
Bone Marrow Transplantation ◽  
Pediatric Oncology ◽  
Disease Free Survival ◽  
Oncology Group ◽  
Free Survival ◽  
Pediatric Oncology Group ◽  
Grade 3 ◽  
Disease Free

Purpose Most children older than 1 year of age with metastatic neuroblastoma (NB) die despite intensive chemotherapy and bone marrow transplantation. The Pediatric Oncology Group conducted a study of paclitaxel, topotecan, and topotecan-cyclophosphamide (topo-cyclo) in newly diagnosed children with stage IV NB. Patients and Methods There were 102 patients enrolled between September 1993 and October 1995; two of them were later shown to be ineligible. Of the remaining 100 patients, the first cohort of 33 patients received paclitaxel 350 mg/m2 intravenously (IV) over 24 hours every 14 to 21 days; the next 33 patients received topotecan 2 mg/m2/d for 5 days IV every 21 days; a third cohort of 34 patients were treated with IV cyclophosphamide 250 mg/m2 followed by topotecan 0.75 mg/m2 each day for 5 days every 21 days. Patients were re-evaluated after two courses and then treated with intensive induction therapy and bone marrow transplantation. Results Objective responses (complete response + partial response + mixed response) were documented in 67% of children who received topotecan, 76% after topo-cyclo, and 25% after paclitaxel. Four patients had grade 3 to 4 allergic reactions to paclitaxel; most patients developed grade 3 to 4 marrow suppression after topotecan or topo-cyclo. Neither disease-free survival nor overall survival differed significantly between children who received a phase II agent and those who did not. The 6-year disease-free survival and overall survival rates for all 100 children were 18% ± 5% and 26% ± 5%, respectively. Conclusion Topotecan and topo-cyclo are active in children with NB, are well tolerated, and should be evaluated further in combination regimens.

A randomized trial of adjuvant chemotherapy in head and neck cancer.

1985 ◽  
Vol 3 (5) ◽  
pp. 672-679 ◽  
Author(s):  
S G Taylor ◽  
E Applebaum ◽  
J L Showel ◽  
M Norusis ◽  
L D Holinger ◽  
...  
Keyword(s):  
Overall Survival ◽  
Head And Neck Cancer ◽  
Adjuvant Chemotherapy ◽  
Head And Neck ◽  
Induction Chemotherapy ◽  
Neck Cancer ◽  
Disease Free Survival ◽  
Free Survival ◽  
Regional Therapy ◽  
Disease Free

Ninety-five patients with squamous cell carcinoma of the head and neck were entered into a randomized study testing a two-week course of induction chemotherapy with methotrexate and leucovorin given prior to regional therapy. In addition, following regional therapy, patients randomized to chemotherapy were to receive similar methotrexate courses every three months for one year. Poor tolerance to this regimen after radiation and surgery led to a change in the chemotherapy following regional therapy to a combination of Adriamycin (Adria Laboratories, Columbus, Ohio) and cisplatin every three weeks for four cycles after the first 35 patients had been entered. Nine cases were ineligible and four lacked any follow-up data, leaving 82 analyzable cases. Using Cox regression analysis, no differences in the percentage of patients achieving disease control, the relapse-free survival, or the overall survival were identified between any treatment group. As has been described in many pilot studies of induction chemotherapy of head and neck cancer, chemotherapy responders had a more favorable disease-free survival than chemotherapy nonresponders in the total group of patients receiving adjuvant chemotherapy. However, correcting for imbalances in the expected three year disease-free survival of these patients, based on their disease site and stage, erased this difference, indicating tumor response to this regimen of chemotherapy is not an independent factor affecting disease outcome. The division of patients into arbitrary prognostic categories based on the expected outcome for each specific tumor site and stage proved to be a useful method for balancing treatment groups, given the multiple site-stage combinations within the upper aerodigestive tract. The defined prognostic categories were the single most sensitive predictors of relapse-free and overall survival.

Adjuvant carboplatin and paclitaxel after concurrent cisplatin and radiotherapy in patients with locally advanced cervical cancer

2019 ◽  
Vol 29 (1) ◽  
pp. 42-47 ◽  
Author(s):  
Guler Yavas ◽  
Cagdas Yavas ◽  
Erdem Sen ◽  
Irem Oner ◽  
Cetin Celik ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Overall Survival ◽  
Adjuvant Chemotherapy ◽  
Locally Advanced ◽  
Disease Free Survival ◽  
Advanced Cervical Cancer ◽  
Free Survival ◽  
Locally Advanced Cervical Cancer ◽  
Grade 3 ◽  
Disease Free

IntroductionStandard treatment for locally advanced cervical cancer (LACC) includes concomitant chemoradiotherapy (CRT) that typically controls localized disease. However, most patients develop distant metastasis, ultimately leading to death.ObjectiveTo determine the role of adjuvant carboplatin and paclitaxel for clinical outcomes in patients with LACC.MethodsBetween 2010 and 2017, 109 patients with LACC were retrospectively evaluated. All patients received cisplatin (40 mg/m2) with concurrent external-beam radiotherapy (up to 50.4 Gy), followed by intra-cavitary brachytherapy. Forty-six of 109 patients received a median of six cycles (range 3–6 cycles) of adjuvant chemotherapy consisting of paclitaxel (175 mg/m2) and carboplatin (CRT + chemotherapy group; area under the curve 5). The remaining 63 patients did not receive adjuvant chemotherapy (CRT group).ResultsDisease-free survival and overall survival after a median follow-up of 24.5 months (range 2.6–94.75 months) were 93.5% and 95.7% and 69.8% and 82.5 % for the CRT + chemotherapy and CRT groups, respectively (p = 0.001, p = 0.012, respectively). No acute grade 3/4 gastrointestinal or genitourinary toxicities were seen during CRT. During adjuvant chemotherapy, the most troublesome side effects were hematologic and neurologic toxicities; however, most were manageable. No chronic grade 3/4 genitourinary toxicities were seen.DiscussionAdjuvant chemotherapy in patients with LACC significantly improved both disease-free survival and overall survival without increasing unmanageable toxicity. Future larger prospective trials are warranted to verify these findings.

scholarly journals On the relation between improved loco-regional control and disease-free survival in head-and-neck cancer

2019 ◽  
Vol 58 (3) ◽  
pp. 390-392
Author(s):  
Katrin Håkansson ◽  
Jacob H. Rasmussen ◽  
Søren M. Bentzen ◽  
Jeppe Friborg ◽  
Lena Specht ◽  
...  
Keyword(s):  
Head And Neck Cancer ◽  
Head And Neck ◽  
Neck Cancer ◽  
Disease Free Survival ◽  
Free Survival ◽  
Regional Control ◽  
Disease Free

Semimonthly Versus Monthly Regimen of Fluorouracil and Leucovorin Administered for 24 or 36 Weeks as Adjuvant Therapy in Stage II and III Colon Cancer: Results of a Randomized Trial

2003 ◽  
Vol 21 (15) ◽  
pp. 2896-2903 ◽  
Author(s):  
Thierry André ◽  
Philippe Colin ◽  
Christophe Louvet ◽  
Erik Gamelin ◽  
Olivier Bouche ◽  
...  
Keyword(s):  
Colon Cancer ◽  
Overall Survival ◽  
Disease Free Survival ◽  
Stage Ii ◽  
Free Survival ◽  
Treatment Groups ◽  
Significant Difference ◽  
Grade 3 ◽  
Disease Free

Purpose: This randomized, 2 × 2 factorial study compared a semimonthly (LVFU2) with a monthly (FULV) regimen of fluorouracil and leucovorin and 24 versus 36 weeks of each regimen as adjuvant treatment of patients with stage II (Dukes’ B2) and III (Dukes’ C) colon cancer. Patients and Methods: LVFU2 was administered semi-monthly for 2 consecutive days as dl- or l-leucovorin (200 or 100 mg/m2, respectively) as a 2-hour infusion, followed by a 400 mg/m2 FU bolus and 600 mg/m2 of FU as a 22-hour continuous infusion. FULV was administered monthly for 5 consecutive days as a 15-minute infusion of dl- or l-leucovorin, followed by 400 mg/m2 of FU as a 15-minute infusion. Results: A total of 905 patients were randomly assigned. The median follow-up was 41 months. Disease-free survival was similar between the LVFU2 and FULV groups (127 v 124 events; hazard ratio [HR] = 1.04; P = .74) and between 24 and 36 weeks of therapy (128 v 123 events; HR = 0.94; P = .63). Analysis of overall survival showed a slight excess in the number of deaths in LVFU2 compared with FULV (73 v 59), but this difference was not statistically significant (HR = 1.26; 95% confidence interval, 0.90 to 1.78; P = .18). The most commonly observed grade 3 to 4 toxicities were neutropenia, diarrhea, and mucositis. Toxicities were significantly lower in the LVFU2 group (all toxicities, P < .001). Conclusion: Our data confirm that LVFU2 is less toxic than FULV. At a median follow-up of 41 months, no statistically significant difference could be detected in disease-free or overall survival between the treatment groups or treatment durations.

scholarly journals Concurrent Doxorubicin Plus Docetaxel Is Not More Effective Than Concurrent Doxorubicin Plus Cyclophosphamide in Operable Breast Cancer With 0 to 3 Positive Axillary Nodes: North American Breast Cancer Intergroup Trial E 2197

2008 ◽  
Vol 26 (25) ◽  
pp. 4092-4099 ◽  
Author(s):  
Lori J. Goldstein ◽  
Anne O'Neill ◽  
Joseph A. Sparano ◽  
Edith A. Perez ◽  
Lawrence N. Shulman ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Overall Survival ◽  
Disease Free Survival ◽  
Metastatic Breast ◽  
Operable Breast Cancer ◽  
Free Survival ◽  
Significant Difference ◽  
Negative Tumor ◽  
Grade 3 ◽  
Disease Free

PurposeThe combination of doxorubicin and cyclophosphamide (AC) is a standard adjuvant regimen. Doxorubicin and docetaxel (AT) is one of the most active cytotoxic regimens for metastatic breast cancer. The purpose of this trial was to determine whether adjuvant AT improved disease-free survival compared with AC in operable breast cancer.Patients and MethodsWomen with invasive breast cancer were eligible if there were one to three positive lymph nodes or if the node-negative tumor was greater than 1 cm. Patients were randomly assigned after surgery to receive doxorubicin (60 mg/m2) plus either cyclophosphamide (600 mg/m2; AC) or docetaxel (60 mg/m2; AT) given every 3 weeks for four cycles, followed by hormone therapy for patients with estrogen receptor (ER) and/or progesterone receptor (PR)–positive tumors.ResultsThere were 2,882 eligible patients enrolled. After a median follow-up of 79.5 months, there was no significant difference in disease-free survival (DFS; 85% in both arms) or overall survival (91% v 92%) at 5 years. The hazard ratio for AC versus AT was 1.02 (95% CI for DFS, 0.86 to 1.22; P = .78). In an exploratory analysis of prespecified stratification factors by ER and PR expression there were trends toward improved DFS for AT in ER/PR-negative disease. Grade 3 neutropenia associated with fever or infection occurred more often with AT (26% v 10%; P < .05).ConclusionAT did not improve DFS or overall survival in this population, and was associated with more toxicity.

Radiation Therapy With Concomitant Hydroxyurea and Fluorouracil in Stage II and III Head and Neck Cancer

1999 ◽  
Vol 17 (2) ◽  
pp. 638-638 ◽  
Author(s):  
Daniel J. Haraf ◽  
Merrill Kies ◽  
Alfred W. Rademaker ◽  
Kerstin Stenson ◽  
Bharat Mittal ◽  
...  
Keyword(s):  
Overall Survival ◽  
Radiation Therapy ◽  
Head And Neck Cancer ◽  
Head And Neck ◽  
Neck Cancer ◽  
Progression Free Survival ◽  
Stage Ii ◽  
Free Survival ◽  
Regional Control ◽  
Local Regional Control

PURPOSE: In 1986, a multi-institutional phase II trial was begun to study the use of chemotherapy with concomitant radiation in patients with stage II and III head and neck cancer. End points were overall survival, progression-free survival, local/regional control, and toxicity in the setting of organ preservation with concomitant treatment. METHODS: Eligible patients with stage II or III disease received chemotherapy and radiation on a 2-week cycle. Chemotherapy consisted of continuous infusion fluorouracil (5-FU) at 800 mg/m2/d for 5 consecutive days (days 1 to 5) and hydroxyurea (HU) at 1 g orally every 12 hours for 13 doses starting the evening before the start of irradiation. Radiation therapy was given as single 1.8- to 2.0-Gy fractions for 5 consecutive days (days 1 to 5) with chemotherapy. Each 5 days of treatment was followed by a 9-day break (days 6 to 14), during which no additional treatment was given. Treatment cycles were repeated until the completion of the planned radiation dose (six to eight cycles). RESULTS: Between 1989 and 1996, 60 patients were enrolled. All patients were eligible for analysis, with a median follow-up of 52 months for surviving patients and 42 months for all patients. Grade 3 to 4 mucositis occurred in 57% of patients. The 5 year-actuarial overall survival, progression-free survival, and local/regional control were 65%, 82%, and 86%, respectively. Eight patients developed local and/or regional recurrence after treatment. Surgical salvage was possible in three of these patients. Thus, the ultimate 5-year local/regional control was 91%. CONCLUSION: Concomitant radiation and chemotherapy with 5-FU and HU is an effective regimen in patients with stage II and III head and neck cancer. Progression-free survival and local/regional control appear to be superior to expected rates in patients treated with surgery and radiation. Further testing of this regimen in a phase III setting is indicated.

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