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Concurrent chemoradiotherapy with cyclophosphamide, pirarubicin, and cisplatin for patients with locally advanced salivary gland carcinoma.

CONCLUSION: This concurrent chemoradiotherapy with CPA, THP, and CDDP showed major antitumor activity with manageable toxicity as treatment of advanced salivary gland carcinoma patients. The high response rate (RR) justifies further evaluation of this chemoradiotherapy combination. OBJECTIVES: The aim of this study was to evaluate the efficacy and toxicity of a concurrent chemoradiotherapy using cyclophosphamide (CPA), pirarubicin (THP), and cisplatin (CDDP) in patients with locally advanced salivary gland carcinoma. PATIENTS AND METHODS: Seventeen patients with previously untreated stage III-IV salivary gland carcinoma were entered in this trial between January 2000 and September 2005. Chemotherapy consisted of CPA 400 mg/m2 on day 1, THP 40 mg/m2 by 6-h infusion on day 1, and CDDP 60 mg/m2 by 2-h infusion on day 1. Radiotherapy (2.0 Gy/fraction/day, mean total dose: 67.2 Gy (64.0-72.0 Gy)) administered 5 days per week, was targeted to begin on day 1. RESULTS: The RR was 76% (13/17) and the pathological complete response (CR) was 24% (4/17). The primary site CR was 29% (5/17) and metastatic lymph node CR was 33% (4/12). The 5-year survival rate was 70%. Neutropenia, leukocytopenia and mucositis were common adverse effects, but all 17 patients were assessable for toxicity.

Aged↗

[A case of mandibular gingival cancer (T4) responding to concurrent chemoradiotherapy with TS-1].

We report here a patient with advanced oral cancer in which concurrent chemoradiotherapy with TS-1 was performed. The patient was an 82-year-old male who had a 41 x 22 mm tumor mass around the left lower gingiva, whose X-ray showed a bone resorption image reaching the mandibular canal. We carried out concurrent chemoradiotherapy with TS-1. After 4 weeks, severe side effects, i.e., stomatitis and diarrhea, force us to discontinue the treatment. However, the tumor had begun to shrink from the 2nd week of treatment, and had clinically disappeared by the 8th week. The histopathological examination also indicated a complete response (CR). Thus, this treatment was very effective and may be useful for advanced cases.

Aged↗

[Concurrent chemoradiotherapy using protracted infusion of low-dose CDDP and 5-FU and radiotherapy for esophageal cancer].

PURPOSE: We evaluated the effects and safety of concurrent chemoradiotherapy for patients with esophageal cancer. MATERIALS AND METHODS: Between March 1994 and April 1998, concurrent chemoradiotherapy using protracted infusion of low-dose cisplatin (CDDP: 3-6 mg/m2/24h), 5-fluorouracil (5-FU: 200 mg/m2/24h) and radiotherapy was given to 26 patients. The median age was 70 yr, with a range from 58 to 86 yr. With regard to TNM classification (1987), six patients were stage II, five stage III, and 15 stage IV. Radiotherapy was performed by external irradiation alone in 23 patients and external irradiation plus brachytherapy in three patients. One patient underwent surgery after a dose of 40 Gy owing to the possibility of idiopathic bleeding from the stomach. RESULTS: Locally, primary effects resulted in complete response in 11 patients (42.3%) and partial response in 15 (57.7%). Acute toxicity was primarily hematologic. Leukopenia and thrombocytopenia of grade 3 or 4 occurred in eight (30.7%) and six (23.0%) of 26 patients, respectively. In patients administered CDDP at more than 5 mg/m2/day, hemotoxicity was severe because in five of the 10 patients administered 5 mg/m2 CDDP and one of the two patients administered 6 mg/m2 CDDP, thrombocytopenia of grade 3 or 4 occurred. CONCLUSION: Protracted infusion of low-dose CDDP and 5-FU with concomitant radiation therapy is effective, but from the point of acute toxicity, the optimal dose of CDDP and 5-FU needs further investigation.

Aged↗

Improved outcome secondary to concurrent chemoradiotherapy for advanced carcinoma of the nasopharynx: preliminary corroboration of the intergroup experience.

PURPOSE: The recent Intergroup 0099 trial of concurrent chemoradiotherapy for advanced nasopharyngeal carcinomas, demonstrated improved survival for chemoradiotherapy as compared to radiation therapy alone. Following closure of this study, we adopted the chemoradiotherapy regimen used in 0099 as our standard of practice. We herein report our recent institutional results, representing a relatively large uniformly treated cohort. METHODS AND MATERIALS: Between 1995 and 1997, 35 consecutive patients, who had clinically nondisseminated Stage III or IV nasopharyngeal cancer, were treated by chemoradiotherapy. The prescribed radiation regimen was 7000 cGy delivered in 35 fractions over 7 weeks to all macroscopic disease and 5000 cGy to areas considered at risk of harboring microscopic disease. Chemotherapy was designed to deliver cisplatin (100 mg/m(2) i.v.) on Days 1, 22, and 43 of radiation therapy and cisplatin (80 mg/m(2) i.v.) on Days 71, 99, and 127 plus flurouracil (5-FU; 1 g/m(2)/day by 96-h infusion) on Days 71-74, 99-102, and 127-130. RESULTS: All patients had at least a partial response (PR) to treatment, including an 85% complete response (CR) rate. The actuarial 3-year overall survival rate was 93% and the disease-free survival rate was 65%. Both represent substantial improvements over our institutional historical controls treated by radiation therapy alone and both are similar to the rates observed in the Intergroup trial. CONCLUSION: Our data support the conclusion that concurrent chemoradiotherapy followed by adjuvant chemotherapy (as was used in Intergroup 0099) should be considered the current standard of care for patients who have advanced cancers of the nasopharynx.

Antineoplastic Combined Chemotherapy Protocols↗

Transvaginal color Doppler sonography for predicting response to concurrent chemoradiotherapy for locally advanced cervical carcinoma.

PURPOSE: This study was conducted to evaluate the potential role of transvaginal color Doppler sonography (TVCD) in predicting response to concurrent chemoradiotherapy for locally advanced cervical cancer. METHODS AND MATERIALS: Tumor vascularity was assessed using TVCD before the start of concurrent chemoradiotherapy in 21 patients (median age, 47 years; range, 31-75 years) with histologically proven locally advanced cervical cancer. The lowest resistance index (RI), lowest pulsatility index (PI), and highest peak systolic velocity (PSV) from central vessels within the tumor were recorded and used for analysis. All patients were clinically evaluated by physical examination and CT scanning after completing the chemoradiotherapy protocol. Complete clinical response (CR) was determined when no residual tumor was found. Partial clinical response (PR) was determined when the tumor volume had decreased more than 50%. RESULTS: CR was achieved in 11 patients (52%), whereas 10 (48%) had PR. The initial median tumor volume was not statistically different between those with CR (26 cm3) and those with PR (28 cm3) (p = 0.71). RI was higher in those tumors with CR (median, 0.47) than in those with PR (median, 0.29) (p < 0.01). Likewise, PI was higher in tumors with CR (median, 0.81) than in those with PR (median, 0.41) (p < 0.01). No differences were found in PSV. The likelihood ratio for CR for tumors with a lowest RI of 0.35 or more was 2.7 (95% confidence interval, 1.8-3.6) and the likelihood ratio for CR for tumors with a lowest PI of 0.45 or more was 3.3 (95% confidence interval, 2.1-4.5). CONCLUSIONS: The results suggest that TVCD may be useful in predicting clinical response to concurrent chemoradiation in patients with locally advanced cervical cancer.

Adult↗

Cisplatin and gemcitabine induction chemotherapy followed by concurrent chemoradiotherapy or surgery for locally advanced non-small cell lung cancer.

BACKGROUND: We report a study of induction chemotherapy followed by concurrent chemoradiotherapy for stage IIIA/IIIB non-small cell lung cancer. METHODS: Patients received two cycles of induction chemotherapy with cisplatin 100 mg/m(2) on day 1 and gemcitabine 1000 mg/m(2) on days 1, 8, and 15 of a 28-day cycle. If the disease was resectable [corrected] surgery was followed with two further cycles. If unresectable, patients received cisplatin 100 mg/m(2) day 1, 29 with 5-fluorouracil 1000 mg/m(2) per 24 h continuous infusion for 96 h on days 2-5 and days 30-33 of the radiotherapy administration. Radiation therapy consisted of 63 Gy, 35 fractions, 7 weeks. RESULTS: Of 48 patients, 40% had a partial response to induction chemotherapy. Four of eleven patients with stage IIIA tumours had resectable disease. The remaining seven patients plus 37 with stage IIIB disease had chemoradiotherapy. Response at the completion of all therapy was 62% (IIIA 73%, IIIB 59%). For all patients the median survival was 15.3 months: 1 year and 3 years, 58% and 25%, respectively. Those with IIIB disease responding to induction chemotherapy had significantly superior survival to those that did not respond (37 months vs 11 months; P = 0.005). This remained significant from a landmark at 8 weeks after the start of treatment (P = 0.01). CONCLUSION: These results are equivalent to other studies using induction chemotherapy prior to concurrent chemoradiotherapy. Response to induction chemotherapy may have major prognostic significance.

Adult↗

"Web-like obstruction"--a sign of regional complete remission after concurrent chemoradiotherapy in small cell lung cancer.

Two patients with small cell lung cancer (SCLC) developed "web-like" mucosa that obstructed bronchi after concurrent chemoradiotherapy. It seemed that the orifice of the bronchi had disappeared. Since the patients were free of local recurrence and the histologic findings of "web-like" mucosa were negative for malignancy, we believe that "web-like obstruction" was additional sign of regional complete remission of SCLC after concurrent chemoradiotherapy.

Aged↗

Effect of preoperative concurrent chemoradiotherapy in locally advanced low rectal cancer after radical resection surgery.

To evaluate the outcome of patients with locally advanced low rectal adenocarcinoma who required preoperative concurrent chemoradiotherapy (CCRT), a total of 22 patients underwent preoperative CCRT and radical resection for locally advanced low rectal adenocarcinoma. Patients received concurrent chemotherapy with high-dose 5-fluorouracil (5-FU) in continuous infusion and leucovorin and preoperative radiation with a mean dose of 50.4 Gy (range, 45-50.4 Gy). Radical resection surgery was performed 6 weeks after treatment. Fifty-five percent of patients achieved tumor downstaging, and 14% patients. showed pathological complete remission. No severe hematological and gastrointestinal toxicity of preoperative CCRT was noted. Sphincter-saving rate was 82%, and there were no deaths related to preoperative CCRT and surgery. Overall, 3-year survival rate was 69%, and a rate of locoregional recurrence was 13.6%. This study shows that many patients with locally advanced rectal cancer can be operated on with sphincter-saving radical resection surgery under good local control after preoperative concurrent chemoradiotherapy, which induces tumor downstaging.

Adenocarcinoma↗

A case of primary small cell carcinoma of the cervical esophagus with long-term survival following concurrent chemoradiotherapy: case report and review of the literature.

The authors describe a case of small cell carcinoma of the esophagus that was treated by concurrent chemoradiotherapy. Both the esophageal tumor and the regional lymph node metastases disappeared after this treatment. The patient is alive and disease free after more than five years. Primary small cell carcinoma of the esophagus is a rare and aggressive neoplasm with a very poor prognosis, and the treatment modality is controversial. This case illustrates the possibility of treating this tumor type with concurrent chemoradiotherapy.

Carcinoma, Small Cell↗

Concurrent chemoradiotherapy with cisplatin, 5-fluorouracil, methotrexate, and leucovorin in patients with advanced resectable squamous cell carcinoma of the larynx and hypopharynx.

CONCLUSIONS: This regimen of concurrent chemoradiotherapy was safe and well tolerated. In terms of larynx preservation, the present regimen appears to be useful for patients with advanced resectable squamous cell carcinoma (SCC) of the larynx and hypopharynx. OBJECTIVES: To evaluate the efficacy and toxicity of concurrent chemoradiotherapy in patients with advanced resectable SCC of the larynx and hypopharynx, and to demonstrate the feasibility of larynx preservation. PATIENTS AND METHODS: Forty-six eligible patients were treated. The chemotherapy regimen consisted of a combination of four drugs: cisplatin (60 mg/m(2), day 4), 5-fluorouracil (5-FU) (600 mg/m(2) given continuously for 120 h, days 1-5), methotrexate (MTX) (30 mg/m(2), day 1), and leucovorin (LV) (20 mg/m(2), days 1-5). Two cycles of this regimen were given every 4 weeks during radiotherapy. Radiotherapy was delivered 5 days a week using a single daily fraction of 1.8-2.0 Gray, to a total dose of 66.6-70.2 Gray. RESULTS: The 3-year disease-specific survival rates of patients with laryngeal or hypopharyngeal SCC were 81.3% and 78%, respectively. The 3-year disease-specific survival rates with larynx preservation of patients with laryngeal or hypopharyngeal SCC were 46.7% and 59%, respectively. The main toxicities were neutropenia, dermatitis, mucositis, and infection.

Adult↗

Postoperative adjuvant concurrent chemoradiotherapy improves survival rates for high-risk, early stage cervical cancer patients.

OBJECTIVE: This study was undertaken to evaluate the efficacy of postoperative concurrent chemoradiotherapy (CCRT) and to investigate the recurrence and survival rates after adjuvant CCRT in high-risk early cervical cancer (stages IA2, IB, IIA) patients who were treated by radical hysterectomy and pelvic lymphadenectomy. METHODS: From July 1994 to June 2001, we retrospectively reviewed the medical records of 151 patients who had undergone radical abdominal hysterectomy with pelvic lymphadenectomy and paraaortic lymph nodes dissection at Ajou University Hospital for early cervical cancer (stages IA2, IB, IIA). CCRT was performed in 30 patients with high-risk factors such as positive pelvic lymph nodes, parametrial involvement, or positive surgical margins. Adjuvant chemotherapy consisted of cisplatin (70 mg/m(2) on day 1) and 5-fluorouracil (5-FU; 1000 mg/m(2) on days 2-5) for four cycles every 4 weeks beginning 2-3 weeks after surgery. Pelvic radiotherapy was started concurrently at the second and third cycle of chemotherapy. We also analyzed the recurrence pattern and survival rates of 114 patients (control group) who received no adjuvant therapy after surgery. The mean follow-up period was 49 months (24-98 months). RESULTS: There were recurrences in three patients after CCRT (10%) and in five patients in the control group (4.4%). The actuarial 5-year overall survival rates for patients in CCRT and control group were 96.7% vs. 97.7%, respectively. The progression-free survival rates were 88.7% for the high-risk group and 95.4% for the non-high-risk group. CONCLUSIONS: This study confirms good local control and 5-year overall and progression-free survival rates in high-risk cervical cancer patients after CCRT, which is comparable with the results of the control group. Our results indicate that adjuvant concurrent chemoradiotherapy seems to be effective in stages IA2-IIA cervical cancer patients with high-risk factors.

Adult↗

Outcome of preoperative concurrent chemoradiotherapy and surgery for resectable lingual squamous cell carcinoma greater than 3 cm: the possibility of less extensive surgery.

We present the outcome of treatment with preoperative concurrent chemoradiotherapy and surgery for resectable lingual squamous cell carcinoma more than 3 cm in its greatest dimension. Twenty patients were enrolled in this study between June 2001 and August 2004. Concurrent chemoradiotherapy included intraarterial pirarubicin (THP) (5 mg/day), intravenous continuous 5-FU, and radiation, usually followed by surgery. Complete response rate was 100%. Notably, 8 of 12 patients who underwent surgery exhibited pathologically complete response, though three patients developed recurrence or distant metastasis. The main adverse effects were mucositis (13/20) and leucopenia (9/20), both of which were acceptable. Although long-term results should be considered, our treatment method appears very useful for lingual squamous cell carcinoma greater than 3 cm, with a remarkably high rate of pathological local control and acceptable adverse events.

Adult↗

Neoadjuvant concurrent chemoradiotherapy followed by definitive high-dose radiotherapy or surgery for operable thoracic esophageal carcinoma.

PURPOSE: A prospective clinical trial was undertaken to investigate the feasibility of concurrent chemoradiotherapy for esophageal carcinomas. MATERIALS AND METHODS: Between June 1989 and May 1996, forty patients with operable squamous cell carcinoma of the thoracic esophagus (Stage 0 to III: UICC 1987), ages 45 to 78 years (mean: 64), were enrolled in a study of neoadjuvant concurrent chemoradiotherapy followed by definitive high-dose radiotherapy (CRT group) or surgery (CRT-S group). Neoadjuvant chemoradiotherapy consisted of 44 Gy in 40 fractions for 4 weeks (2.2 Gy/2 Fr/day) through 10-MVX rays, with 2 courses of cisplatin (80-100 mg/body, mean: 60 mg/m2, Day 1, bolus injection) and 5-fluorouracil (500-1000 mg/body/day, mean: 400 mg/m2, Days 1-4, continuous infusion). After completion of neoadjuvant chemoradiotherapy, an intermediate clinical response was assessed by barium swallow, esophagoscopy with/without biopsy, EUS in most cases, thoracic and upper abdominal CT scan, and cervical US. Definitive chemoradiotherapy was performed in patients when regression of more than 75% was evident (CRT Group), and esophageal resection was indicated in those who remained at less than 75% (CRT-S Group). In CRT Group, a cumulative dose of 60-70 Gy for Tis, T1 and 65-75 Gy for T2-T4 tumor with high-dose-rate intraluminal brachytherapy and a total of 3 courses of chemotherapy were planned. In CRT-S Group, intraoperative radiotherapy for abdominal lymphatic system and postoperative supraclavicular irradiation were added. RESULTS: At the time of intermediate assessment, complete response (CR) was observed in 16 patients, a partial response (PR) in 22, and no change (NC) in 2. Thirty responding patients (CR, 16; PR, 14) entered the CRT Group, and 10 nonresponding patients (PR, 8; NC, 2) were followed by surgery (CRT-S Group). Radiotherapy was completed satisfactorily, but chemotherapy was suspended in 26 patients (65%) because of acute toxicity. Clinical CR rate at the completion of treatment showed 90% in CRT Group, and pathologic CR rate 10% in CRT-S Group. The overall median survival was 45 months, survival at 1, 2, and 3 years being 100%, 72%, and 56%, respectively. Local-regional failure was observed in 7 patients (all in CRT Group), distant failure in 6 (3 in CRT Group, 3 in CRT-S Group) and local-regional with distant failure in 1 (CRT Group). Four patients with local-regional recurrence in the CRT Group were salvaged by surgery. Overall survival at 2 and 3 years for CRT vs. CRT-S Group was 72%, 64% vs. 75%, 38%, respectively. No treatment-related mortality was observed. The rate of the 'esophagus conservation' was 65% (Stage 0: 1 of 1, 100%; Stage I: 11 of 12, 92%; Stage II: 8 of 17, 47%; Stage III: 6 of 10, 60%). CONCLUSION: Our results demonstrated that almost all early disease (Stage 0-I) and about half of advanced disease (Stage II-III) could be conserved, their esophagus treated by the multidisciplinary approach centering on high-dose radiotherapy and concurrent chemotherapy.

Aged↗

Phase II study of concurrent chemoradiotherapy with capecitabine and cisplatin in patients with locally advanced squamous cell carcinoma of the head and neck.

We aimed to evaluate the efficacy and safety of concurrent chemoradiotherapy with capecitabine and cisplatin in patients with locally advanced squamous cell carcinoma of the head and neck (SCCHN). In total, 37 patients with stage III or IV SCCHN were enrolled on the study. The chemotherapy consisted of two cycles of intravenous cisplatin of 80 mg m(-2) on day 1 and oral capecitabine 825 mg m(-2) twice daily from day 1 to day 14 at 3-week intervals. The radiotherapy (1.8-2.0 Gy 1 fraction day(-1) to a total dose of 70-70.2 Gy) was delivered to the primary tumour site and neck. The primary tumour sites were as follows: oral cavity (n=6), oropharynx (n=11), hypopharynx (n=8), larynx (n=3), nasopharynx (n=6), and paranasal sinus (n=3). After the chemoradiotherapy, 29 complete responses (78.4%) and 6 partial responses (16.2%) were confirmed. Grade 3 or 4 neutropenia occurred only in two patients, plus grade 3 febrile neutropenia was observed only in one patient. At a median follow-up duration of 19.8 months, the estimated overall survival and progression-free survival rate at 2-year was 76.8 and 57.9%, respectively. Concurrent chemoradiotherapy with capecitabine and cisplatin was found to be well tolerated and effective in patients with locally advanced SCCHN.

Adult↗

Postoperative concurrent chemoradiotherapy with mitomycin in advanced squamous cell carcinoma of the head and neck: results from three prospective randomized trials.

UNLABELLED: Recent prospective randomized trials have shown concurrent chemoradiotherapy improves locoregional control in postoperative patients with squamous cell carcinoma of the head and neck using cisplatin-based regimes. This report presents data pooled from three randomized trials employing mitomycin, selecting those patients treated postoperatively, to evaluate the long-term benefit of mitomycin in the postoperative setting and to compare these results with those of two other recently published randomized trials. METHODS AND MATERIALS: Between 1980 and 1999, a total of 331 patients with squamous cell carcinoma of the head and neck from the three prospective trials were enrolled. Of the 205 postoperative patients in these trials, 103 were randomized to receive mitomycin and radiation, while 102 received radiation alone or radiation with porfiromycin in the third trial. Patients were treated with standard daily radiotherapy to a total median dose of 60 Gy over 47 days. Patients who were randomized to mitomycin C received 15 mg/m2 of the drug on days 5 and 47 (or last day). RESULTS: The 5-year rate of locoregional control was higher in the mitomycin arms. There was no statistically significant difference in the rates of overall survival or distant metastasis. Patients had a lower percentage of high-risk factors in both arms of the study, compared with patients in the large prospective trials, including positive margins, two or more positive lymph nodes, or oropharynx primary tumors. The gains in locoregional control realized with mitomycin were similar to the improvements in the recently published randomized trials using platinum. CONCLUSIONS: These results confirm significant gains in locoregional control using concurrent chemoradiotherapy in the postoperative setting for patients with squamous cell carcinoma of the head and neck. The lack of consensus over a benefit in the rates of overall survival and distant metastasis emphasizes the need for further prospective trials in the postoperative management of squamous cell carcinoma of the head and neck.

Antibiotics, Antineoplastic↗

Concurrent chemoradiotherapy with doxifluridine and paclitaxel for extrahepatic bile duct cancer.

OBJECTIVES: Bile duct cancer is a rare malignancy with poor prognosis. We sought to determine the efficacy of concurrent chemoradiotherapy with doxifluridine and paclitaxel for extrahepatic bile duct cancer. METHODS: Nineteen patients with unresectable extrahepatic bile duct cancer received doxifluridine (600 mg/m2) daily, intravenous paclitaxel (50 mg/m) weekly (before radiotherapy), and radiotherapy of 4500 cGy for approximately 5 weeks. RESULTS: Local response rate which reflected the reopening of occluded bile duct was 89.5% (17 out of 19). In 6 cases (31.6%), overall response, which measured the change of tumor size, was achieved with this treatment. The longest survival time was 52 months, and median survival time was 14 months. One- and 2-year survival rates were 84.2% and 31.6%, respectively. One case of gastrointestinal bleeding and 1 case of grade III leukopenia occurred during the treatment. One patient could not finish the treatment because of poor general condition. CONCLUSIONS: Concurrent chemoradiotherapy with doxifluridine and paclitaxel seemed to produce a good clinical response without severe toxicity and improve survival rates in patients with extrahepatic bile duct cancer.

Administration, Oral↗

Esophagectomy after concurrent chemoradiotherapy improves locoregional control in clinical stage II or III esophageal cancer patients.

PURPOSE: To evaluate the effect of surgical resection on the outcome of patients with clinical Stage II or III cancer of the esophagus treated with concurrent chemoradiotherapy. METHODS AND MATERIALS: A retrospective review of 132 consecutive patients with clinical Stage II or III esophageal cancer treated with concurrent chemoradiotherapy between January 1990 and December 1998 was performed. Of the 132 patients, 60 underwent esophagectomy 6-8 weeks after chemoradiotherapy. The median radiation dose was 50 Gy (range, 30-64.8 Gy) in the definitive chemoradiation group and 45 Gy (range, 30-50.4 Gy) in the chemoradiation plus esophagectomy group. RESULTS: Statistically significant differences were found between the two groups in median age, histologic subtype, tumor location, and number of patients with T4 disease. Patients who underwent definitive chemoradiotherapy were older (p = 0.0004) and more likely to have squamous cell carcinoma than adenocarcinoma (p <0.000), upper thoracic or cervical esophageal tumors (p <0.000), and T4 tumors (p = 0.024). Patients treated with chemoradiation plus esophagectomy had statistically significant superior 5-year loco-regional control (67.1% vs. 22.1%, p <0.000), disease-free survival (40.7% vs. 9.9%, p < 0.000), and 5-year overall survival (52.6% vs. 6.5%, p < 0.000) rates and median survival time (62 vs. 12 months) compared with patients treated with chemoradiotherapy only. However, no statistically significant difference was found in the rate of distant metastasis-free survival between the two groups (67.5% vs. 65.8%, p = 0.3). Surgical resection of the tumor was an independent predictor of improved locoregional control and overall survival in both univariate and multivariate analyses. To reduce the effect of the selection bias on the outcome, 34 patients in each group with matched pretreatment characteristics were compared. The results showed statistically significant better overall survival, disease-free survival, and locoregional control in favor of the chemoradiotherapy plus esophagectomy group. No statistically significant difference in distant metastasis-free survival was found in this subgroup analysis. CONCLUSIONS: Locoregional control was better in clinical Stage II or III esophageal cancer patients treated with concurrent chemoradiation plus esophagectomy. An improvement in survival occurred in the chemoradiation plus esophagectomy group, although this observation may have reflected selection bias. The results from this study suggest the need for a randomized trial to compare chemoradiation with or without esophagectomy in the treatment of cancer of the esophagus.

Adenocarcinoma↗

Concurrent chemoradiotherapy with low-dose cisplatin plus 5-fluorouracil for the treatment of patients with unresectable head and neck cancer.

OBJECTIVE: The purpose of this study was to determine the efficacy of concurrent chemoradiotherapy using conventional radiotherapy combined with low-dose daily 5-fluorouracil (5FU) and cisplatin (CDDP) for the locally unresectable head and neck cancer patients. PATIENTS AND METHODS: From September 1996 through December 2000, we carried out a phase II study of concurrent chemoradiotherapy with low-dose CDDP plus 5FU for the treatment of patients with unresectable squamous cell carcinoma of the head and neck. Chemoradiotherapy consisted of irradiation with 1.6-2.0 Gy/day for 5 days per week up to a total dose 68 Gy and CDDP 3 mg/m2 by intravenous infusion over 1 h plus 5FU 150 mg/m2 by intravenous infusion over 24 h per day for 5 days per week. RESULTS: Ninety percent of the patients had stage IV disease, including 65% of patients with T4 disease. Thirty-three patients (83%) received the full treatment as planned; 39 (98%) received full-dose radiotherapy and 33 (83%) full-dose chemotherapy. Of the 40 patients evaluable for response, 20 (50%) achieved complete response (CR) and 12 (30%) partial response with an overall response rate of 80%. Among the 20 CR patients, 15 underwent endoscopic blind biopsies and 4 had positive lesions. The most frequently observed toxicity was mucositis. Ten patients developed grade III mucositis, and 3 patients required enteral nutritional support through a feeding tube. Grade III leukopenia, anemia and thrombocytopenia were observed in 28, 25 and 20% of the patients, respectively. The median duration of follow-up at the time of analysis was 18 months. The median survival time was 23 months. The responders survived longer (34 months) than the nonresponders (4 months; p < 0.05). CONCLUSION: This regimen is safe and efficacious in the treatment of patients with advanced unresectable head and neck cancer.

Adult↗