6-Year Experience of Concurrent Radiochemotherapy with Vinorelbine Plus a Platinum Compound in Multimorbid or Aged Patients with Inoperable Non-Small Cell Lung Cancer

BACKGROUND AND PURPOSE: Although poor-risk patients represent no minority in inoperable non-small cell lung cancer (NSCLC), there is little experience with concurrent radiochemotherapy (RCT) in this group. Here, the authors report on the feasibility and efficacy of RCT with vinorelbine plus carboplatin or cisplatin in NSCLC patients with comorbidities and poor general health or advanced age. PATIENTS AND METHODS: A total of 66 patients (ten women, 56 men, median age 68 years) with inoperable NSCLC and an increased risk of treatment side effects (WHO performance score of 2-3; cardiac, pulmonary or renal failure or extensive weight loss before treatment, or an age of 71-78 years) were treated with vinorelbine 12.5 mg/m(2) on days 1, 8, 15, 29, 36, and 43 in combination with either carboplatin 70 mg/m(2) (n = 59) or cisplatin 20 mg/m(2) (n = 7) on days 1-5 and 29-33 in addition to receiving conventional fractionated radiotherapy with doses of up to 63 Gy (90% isodose). RESULTS: 62 of 66 patients (94%) reached the 90% level of the prescribed radiation dose, and 41/66 patient (62%) received at least two cycles of the platinum compound and four cycles of vinorelbine. The following hematologic side effects (CTC classification [Common Toxicity Criteria]) were observed: grade 3 (12%) and grade 4 (15%) thrombocytopenia, grade 3 (38%) and grade 4 (4%) leukocytopenia, and anemia requiring transfusion (26%). Other side effects (CTC) included grade 3 (3%) and grade 4 (2%) esophagitis and grade 3 pneumonitis (3%). The response rates were as follows: complete remission 18%, partial remission 56%, stable disease 21%, and progressive disease 5%. The cumulative survival rates were 53%, 24%, and 8% at 12 months, 24 months, and 5 years, respectively. CONCLUSION: After including a larger group of patients than in 2003 and following the patients for several years, the authors determine that concurrent RCT consisting of vinorelbine plus a platinum compound and conventional fractionated radiotherapy can be carried out with manageable toxicity, even in this negatively selected population of patients. Their survival rates were comparable to those achieved in other studies with simultaneous RCT.     

Radiotherapy is an Effective Treatment for High-Risk T1-Bladder Cancer

PURPOSE: Current treatment options for high-risk superficial T1-bladder cancer (Grade 3, associated Tis, multifocality, tumor diameter > 5 cm or multiple recurrences) include early cystectomy or the goal of organ preservation by adjuvant intravesical therapy after transurethral resection (TURB). We have evaluated the efficacy of adjuvant radiotherapy or radiochemotherapy on local control, bladder preservation, recurrence rate and long-term survival after TURB of high-risk T1-bladder cancer. PATIENTS AND METHODS: From May 1982 to May 1999, a total of 74 patients with T1-bladder cancer were treated by either radiotherapy (n = 17) or concomitant radiochemotherapy (n = 57) after TURB. Radiotherapy was initiated 4 to 8 weeks after TURB; a median dose of 54 (range: 45 to 60) Gy was applied to the bladder with daily fractions of 1.8 to 2.0 Gy. Since 1985 chemotherapy has been given in the 1st and 5th week of radiotherapy and consisted of cisplatin (25 mg/m2/d) in 33 patients, carboplatin (65 mg/m2/d) was administered in 14 patients with decreased creatine clearance (< 50 ml/min). Since 1993 a combination of cisplatin (20 mg/m2/d) and 5-fluorouracil (600 mg/m2/d) was applied to 10 patients. Salvage cystectomy was recommended for patients with refractory disease or invasive recurrences. At the time of analysis, the median follow-up for surviving patients was 57 (range: 3 to 174) months. RESULTS: After radiotherapy/radiochemotherapy, a complete remission at restaging TURB was achieved in 62 patients (83.7%), 35 of whom (47% with regard to the total cohort of the 74 treated patients) have been continuously free of tumor, 11 patients (18%) experienced a superficial relapse and 16 patients (26%) showed tumor progression after initial complete response. Overall-survival was 72% at 5 years and 50% at 10 years with 77% of the surviving patients maintaining their own bladder at 5 years. Negative prognostic factors for cancer-specific survival were non-complete (R1/2) initial TURB (p = 0.12) and recurrent disease (p = 0.07); combined radiochemotherapy was more effective than radiotherapy alone (p = 0.1). CONCLUSION: Adjuvant radiotherapy/radiochemotherapy offers an additional option in high-risk superficial bladder cancer with a high chance of cure and bladder preservation. The ultimate value of radiotherapy in comparison with other treatment options should be determined in randomized trials.     

The multimodality therapy of advanced inoperable esophageal carcinoma. A retrospective analysis]

BACKGROUND: The records of 161 patients with inoperable esophageal carcinoma were reviewed to determine the influence of concurrent radiochemotherapy and brachytherapy on overall survival. PATIENTS AND METHODS: From 1984 to 1999 161 patients suffering from advanced esophageal carcinoma Stage II to IV were treated with radiotherapy alone (131) or radiochemotherapy (30). In 48 patients additional brachytherapy was given. Median follow-up was 8 months (1 to 64 months), the median external beam doses was 51 Gy (18 to 66.6 Gy) and the median brachytherapy dose was 10 Gy (4 to 25 Gy). Chemotherapy consisted of cisplatin and 5-fluorouracil. RESULTS: Median survival for all patients was 10 months, 3-year survival rate 13% and the 5-year survival 5.2%. In univariate analysis the best results were achieved by concurrent radiochemotherapy with a median overall survival of 13 months, a 4-year survival of 18% (p = 0.0368), the combination of external radiotherapy and additional brachytherapy with a median overall survival of 14 months, a 4-year survival of 12.2% (p = 0.0008). After combination of concurrent radiochemotherapy and brachytherapy the 2-year survival rate is 58%. Multivariate analysis revealed simultaneous radiochemotherapy, external beam dose and additional brachytherapy as prognostic factors. Combination of concurrent radiochemotherapy and brachytherapy was possible without significant increase of local toxicity. CONCLUSIONS: Our retrospective analysis demonstrates that concurrent radiochemotherapy and additional brachytherapy are effective treatment schedules without significant increase of toxicity and may improve overall survival of patients with inoperable carcinoma of the esophagus. According to the results of this retrospective study, it would be appropriate to conduct a randomized trial to evaluate the benefit of combination of concurrent radiochemotherapy and brachytherapy.     

Temozolomide Combined with Irradiation as Postoperative Treatment of Primary Glioblastoma Multiforme

BACKGROUND AND PURPOSE: The role of radiochemotherapy in the treatment of primary glioblastoma multiforme is still discussed controversially. To evaluate the feasibility and toxicity of irradiation and concomitant administration of 50 mg/m(2) temozolomide in patients with primary malignant glioma, this phase I/II study was conducted. PATIENTS AND METHODS: 53 Patients with histologically confirmed WHO grade IV malignant glioma were enrolled into the study. All patients were treated with radiation therapy up to a total dose of 60 Gy using conventional fractionation of 5 x 2.0 Gy/week. Temozolomide was administered orally each therapy day at a dose of 50 mg/m(2). RESULTS: Prior to radiochemotherapy, complete resection (n = 14), subtotal resection (n = 22) or a biopsy (n = 17) of the tumor was performed. The median time interval between surgery and radiochemotherapy was 21 days. Treatment-related toxicity was very mild. Acute toxicity > grade 2 was observed in one patient who developed grade 4 hemotoxicity. Minor side effects of chemotherapy included nausea and vomiting. No severe late effects were observed. Median progression-free and overall survival were 8 and 19 months, respectively. The overall survival rate was 72% at 1 and 26% at 2 years. Age and extent of surgery significantly influenced survival. CONCLUSION: The combination of temozolomide plus radiation therapy is feasible and safe in terms of toxicity. Overall survival times were relatively long compared to survival times reported for radiotherapy alone. The application of 50 mg/m(2) of temozolomide can be performed throughout the whole time course without interruption due to side effects and might largely contribute to the prolonged overall survival. Further evaluation is warranted as to which dose of temozolomide is optimal with regard to tumor response and toxicity.     

Simultane radiochemotherapie mit carboplatin bei patienten mit inoperablen fortgeschrittenen Kopf-Hals-Tumoren der stadien UICCIII und IV

BACKGROUND: The results of treating advanced tumors in the head and neck region with radiotherapy alone are disappointing. Concurrent radiotherapy and chemotherapy may improve this situation. The treatment results of concurrent radiochemotherapy at the University of Rostock were analyzed retrospectively. PATIENTS AND METHODS: From 1991 to 1996 92 patients with head and neck tumors were treated with concurrent radiochemotherapy (1.8 to 63 Gy; 70 mg/m2 carboplatin day 1 to 5 and 29 to 33) with palliative tumor resection (n = 37) or without surgical treatment (n = 55). Remission rate, overall survival and disease-free survival, local control and acute toxicity were analyzed. RESULTS: Six weeks after radiochemotherapy 56.5% of patients had a complete remission, 36% a partial remission and 7.5% "no change". With a median follow-up of 42 months (6 to 74 months) overall survival, disease-free survival and local control were 24.3%, 28.9%, 18.0% 5 years after treatment. All these criteria were significantly better in patients with palliative tumor resection compared to no surgical treatment (uni- and multivariate) and in patients with Stage III than in patients with Stage IV carcinomas (univariate), overall survival was significantly better in patients with Stage III (multivariate). A pretherapeutic Hb level below 7.0 mmol/l (11.27 g/dl) reduced the local control significantly (uni- and multivariate). Grade III and IV mucositis was detected in 10%, Grade III leucopenia in 12% of treated patients. Grade IV leucopenia and Grade III thrombopenia were observed in 1 patient each. CONCLUSION: The toxicity of this treatment is tolerable. However, additional trials must be conducted before considering the palliative tumor resection as standard therapy.     

Usefulness of Tumor Volumetry as a Prognostic Factor of Survival in Head and Neck Cancer

BACKGROUND: The TNM classification system of tumor stage does not always reflect the actual tumor mass present at diagnosis. This study aimed at evaluating the prognostic value of volumetric data regarding survival in head and neck cancer patients being treated with either cisplatin or carboplatin administered concomitantly with radiotherapy. PATIENTS AND METHODS: We retrospectively analyzed 107 patients suffering from squamous cell carcinoma of the head and neck in a Greek-German cooperative study (see Table 1). All patients were treated by radiotherapy and concomitant chemotherapy. 65 patients received chemotherapy with carboplatin and 42 with cisplatin. More than 6,200 CT scans were analyzed by digitalization of contours which subsequently led to the computation of the tumor volume (primary and macroscopic lymph node metastases). RESULTS: Median follow-up was 43 months and median survival 30 months. Median initial tumor volume was 32.5 ml (range 2.1-220.1 ml) in the carboplatin and 44.4 ml (range 3.2-202.5 ml) in the cisplatin group (see Figure 1). After treatment, tumor volumes did not differ significantly (median of 3.1 ml [range 0.0-167.1 ml] and 3.5 ml [range 0.0-166.0 ml], respectively). 41 patients (63.1%) died in the carboplatin group and 22 patients (52.4%) in the cisplatin group (see Figure 2). Pretherapeutic tumor volume was prognostic with respect to survival while TNM classification and age were not. Pretherapeutic tumor volume was negatively and percent decrease in tumor volume positively associated with survival (see Tables 2 and 3). CONCLUSION: Knowledge of the initial tumor volume adds valuable information in terms of prognosis. Initial tumor volume should be included in all future clinical trials regarding head and neck cancer patients.     

氨磷汀配合紫杉醇和顺铂同步放化疗治疗局部晚期非小细胞肺癌的临床分析

目的观察氨磷汀联合同步放化疗治疗局部晚期非小细胞肺癌的疗效及对正常组织的保护作用与安全性。方法60例Ⅲa~Ⅲb期的非小细胞肺癌,随机分为两组,对照组(n=30例):同步放化疗,未使用氨磷汀预处理;治疗组(n=30例):同步放化疗,使用氨磷汀预处理(300 mg/m2.d-1)。化疗方案为紫杉醇(60 mg/m2)联合顺铂(30 mg/m2),放疗应用6MV X线,2 Gy/次,5次/周,总剂量50~60Gy。治疗期间评价血细胞变化、食管炎、急性肺毒性及近期疗效。结果两组患者的临床特征比较无显著差异,治疗组食管炎的发病率明显低于对照组(43%和83%,P<0.01),治疗组急性肺毒性的发病率明显低于对照组(27%和54%,P<0.05),对照组的有效率(CR+PR)为80.0%,对照组为86.7%,二者无统计学意义(P>0.05)。结论氨磷汀能有效减少局部晚期非小细胞肺癌的同步放化疗的急性毒副作用,且不降低抗肿瘤效应。     

吉西他滨单药或联合卡铂治疗老年晚期非小细胞肺癌疗效观察

 目的 评价吉西他滨单药或与卡铂联合对老年晚期非小细胞肺癌(NSCLC)化疗的安全性和可行性.方法 48例年龄≥65岁的晚期NSCLC患者随机分为单药治疗组和联合用药组.单药治疗组:盐酸吉西他滨1000 mg/m2,静脉滴注,第1、8天,21 d为一疗程.联合用药组:吉西他滨1000 mg/m2,静脉滴注,第1、8天;卡铂,第1天,以AUC=5计算所得的剂量静脉滴注.21 d为一疗程.结果 单药治疗组有效率为20.8%;联合用药组有效率33.3%,两组有效率差异有统计学意义(P＜0.05).单药治疗组中位生存期8.2个月,1年生存率32.1%.联合用药组中位生存期9.6个月,1年生存率为39.4%;两组1年生存率比较,差异无统计学意义(P＞0.05).联合用药组3～4级白细胞和血小板减少发生率均显著增高(P＜0.05),但粒细胞减少性发热、感染及出血的发生率并没有显著增加.结论 吉西他滨单药或吉西他滨联合卡铂均是治疗老年晚期NSCLC的较好方案,不良反应均可耐受.     

Organ-Sparing Treatment of Advanced Bladder Cancer

BACKGROUND AND PURPOSE: Transurethral resection of bladder tumor (TUR-BT) and radiochemotherapy with cisplatin achieve high rates of bladder preservation and survival figures identical to radical cystectomy in muscle-invasive bladder cancers. The authors have investigated the potential use of paclitaxel in a radiochemotherapy protocol for patients with inoperable bladder carcinomas and mainly contraindications to cisplatin. PATIENTS AND METHODS: Between October 1997 to August 2004, 42 patients (median age 71 years) suffering from muscle-invasive (n=32) or recurrent (n=10) bladder cancers were treated with a paclitaxel-containing radiochemotherapy (paclitaxel 25-35 mg/m(2) twice weekly) after TUR-BT (R0/1/2/x in n=18/4/14/3) or cystectomy with residual tumor (n=3). Five patients received additional cisplatin. Radiation treatment was administered to a total dose of 45-60 Gy. RESULTS: 76.2% completed the planned regimen. Adaptations of treatment were mainly required due to diarrhea. Grade 3/4 toxicities occurred in 15/1 patients. Severe renal toxicities did not occur. 28 patients underwent restaging TUR-BT 6 weeks after radiochemotherapy (complete remission/partial remission/progressive disease: n=24/3/1). Three patients developed a local recurrence and four distant metastases. Seven patients died from tumor, six of other reasons. CONCLUSION: Radiochemotherapy with paclitaxel was feasible and this bladder approach needs further investigation to evaluate whether paclitaxel could become a substitute for cisplatin.     

Radiochemotherapy in Combination with Regional Hyperthermia in Preirradiated Patients with Recurrent Rectal Cancer

BACKGROUND AND PURPOSE: Encouraging results of phase II studies combining chemotherapy with radiotherapy have been published. In this study, the results of a multimodal salvage therapy including radiochemotherapy (RCT) and regional hyperthermia (RHT) in preirradiated patients with recurrent rectal cancer are reported. PATIENTS AND METHODS: All patients enrolled had received previous pelvic irradiation (median dose 50.4 Gy). The median time interval between prior radiotherapy and the onset of local recurrence was 34 months. The combined treatment consisted of reirradiation with a median dose of 39.6 Gy (30.0-45.0 Gy), delivered in fractions of 1.8 Gy/day. 5-fluorouracil was given as continuous infusion 350 mg/m(2)/day five times weekly, and RHT (BSD-2000 system) was applied twice a week within 1 h after radiotherapy. The primary endpoint was local progression-free survival (LPFS); secondary endpoints were overall survival, symptom control, and toxicity. RESULTS: 24 patients (median age 59 years) with a previously irradiated locally recurrent adenocarcinoma of the rectum were enrolled. The median LPFS was 15 months (95% confidence interval 12-18 months] with a median follow-up of 27 months (16-37 months). The overall 1-year and 3-year survival rates were 87% and 30%, respectively. Pain was the main symptom in 17 patients. Release of pain was achieved in 12/17 patients (70%). No grade 3 or 4 hematologic or skin toxicity occurred. Grade 3 gastrointestinal acute toxicity was observed in 12.5% of the patients. Paratumoral thermometry revealed a homogeneous distribution of temperatures. CONCLUSION: RCT combined with RHT is an efficient salvage therapy showing high efficacy with acceptable toxicity and can be recommended as treatment option for this unfavorable group of preirradiated patients with local recurrence of rectal cancer.     

Aggressive Simultaneous Radiochemotherapy with Cisplatin and Paclitaxel in Combination with Accelerated Hyperfractionated Radiotherapy in Locally Advanced Head and Neck Tumors

BACKGROUND: Simultaneous radiochemotherapy (sRCT) is the treatment of first choice in locally advanced head and neck cancers. We have tested a very aggressive combination protocol with cisplatin and escalated paclitaxel in combination with accelerated hyperfractionated radiotherapy to assess the maximum tolerated dose (MTD), dose-limiting toxicity (DLT), overall toxicity, and response rate. PATIENTS AND METHODS: The trial recruited 24 patients (21 males, three females, mean age 57 years) treated at our department from 1998 through 2001. Irradiation was administered in daily doses of 2 Gy up to 30 Gy followed by 1.4 Gy twice daily up to 70.6 Gy to the primary tumor and involved nodes and 51 Gy to the clinically negative regional nodes. The chemotherapy schedule included cisplatin in a fixed dose of 20 mg/m(2) on days 1-5 and 29-33 and paclitaxel at increasing dose levels of 20, 25, 30 mg/m(2) twice weekly over the whole treatment time. Patients were recruited in cohorts of three to six, and the MTD was reached if two out of six patients in one cohort developed DLT. DLT was defined as any grade 4 toxicity or any grade 3 toxicity requiring treatment interruption or unplanned hospitalization or any grade 3 neurotoxicity. We recruited mainly patients with large tumors for this protocol; all patients were stage IV, and the mean tumor volume (primary + metastases) amounted to 72 +/- 61 cm(3). The mean follow-up was 30 months (range 4-39 months). RESULTS: One early death (peritonitis and sepsis at day 10) occurred, and 23 patients were evaluable for acute toxicity and response. The MTD of paclitaxel was reached at the third dose level (30 mg/m(2) paclitaxel twice weekly). The DLT was severe mucositis grade 3 (n = 1) and skin erythema grade 4 (n = 2). After determining the MTD, another 14 patients were treated at the recommended dose level of paclitaxel with 25 mg/m(2) twice weekly. In summary, 13/23 patients (57%) developed grade 3 and 10/23 (43%) grade 2 mucositis. Two patients (9%) had grade 4, five (22%) grade 3, and 16 (69%) grade 2 dermatitis. One patient died at day 30 of neutropenic infection. In one patient, a grade 2 nephrotoxicity appeared requiring cessation of cisplatin chemotherapy. 18/23 patients (78%) required blood transfusion (1-3 units) and 16/23 (70%) i.v. antibiotics. 14 patients (61%) achieved a complete and nine (39%) a partial remission, yielding an overall response rate of 100%. In summary, six patients died of local tumor progression (n = 2), distant metastases (n = 2), or therapy-related complications (n = 2) during follow-up. The 3-year overall survival was 71%. Tumor volume was not a risk factor for failure in this protocol (mean tumor volume in relapse-free vs. progressive patients 71 +/- 65 cm(3) vs. 64 +/- 38 cm(3)). All patients have, so far, developed only slight late effects (fibrosis, lymphedema) with no grade 3-4 late sequelae. CONCLUSIONS: This very aggressive sRCT protocol yielded excellent response and survival figures but was associated with a very high rate of acute toxicity (8% therapy-related deaths). A maximal supportive treatment is therefore required.     

Neoadjuvant Radiochemotherapy in Locally Advanced Gastric Carcinoma

BACKGROUND AND PURPOSE: Gastric carcinoma is characterized by a high rate of local recurrences and distant metastases and is often not resectable due to locally advanced stage. The aim of this study was to examine feasibility and effectiveness of neoadjuvant radiochemotherapy (RCT) for locally advanced, primarily nonresectable gastric carcinoma and to achieve curative resection. PATIENTS AND METHODS: 21 patients with locally advanced gastric cancer located in cardia (n = 17) and corpus (n = 4; seven cT3; 14 cT4; 18 cN+; all cM0) with a median age of 61 years were scheduled to receive neoadjuvant RCT. Therapy consisted of a conventionally fractionated, conformal radiotherapy using the shrinking-field technique (1.8 Gy to 45 Gy + 5.4 Gy) and chemotherapy using cisplatin (20 mg/m(2), d1-5, 29-33), 5-fluorouracil (5-FU; 800 mg/m(2), d1-5, 29-33) or paclitaxel (135 mg/m(2), d1, 29). 4-6 weeks after completion of RCT, surgery was performed whenever feasible. RESULTS: Hematologic toxicity was moderate with grade 3 leukopenia in 10/21 patients and grade 3 thrombopenia in 5/21 (CTC). Nonhematologic toxicities consisted of 5/21 cases of fever as well as one fungal sepsis. Following RCT, tumors were classified resectable in 16/21 patients (76%); 12/21 patients (58%) were operated on, 11/12 achieved clear margins (R0). Response was as follows: complete remission (CR) 3/21 (14%), partial remission 13/21 (62%), no change 3/21 (14%), systemic progressive disease (PD) 2/21 (10%). The median survival and the 2-year survival rates were 18 months and 42%, respectively, for the patients following R0 resections as compared to 10 months and 0% for the remaining patients (p = 0.035). Local control (4 years) for patients following R0 resection was 89%. CONCLUSION: Neoadjuvant RCT is feasible and locally highly effective but must be further investigated involving a higher number of patients.     

Concurrent Radiochemotherapy of Locally Recurrent or Advanced Sarcomas of the Uterus

BACKGROUND: Uterine sarcomas are rare tumors. Until now, no data on the treatment of recurrent or advanced uterine sarcomas using concurrent radiochemotherapy (RCT) has been available. PATIENTS AND METHODS: From 01/1997 to 03/2004, seven patients with locally recurrent (n = 6) or locally advanced uterine sarcomas (n = 1) received concurrent RCT after tumor surgery (R1/2 resection in 3/7 patients). A total radiation dose of 45 Gy was applied in single doses of 1.8 Gy using an external-beam technique; in addition, three to four intracavitary doses of 5 Gy were applied. Concurrent chemotherapy was generally administered as follows: 1.2 g/m(2) ifosfamide on days 1-5 and 29-33 in combination with 50 or 40 mg/m(2) adriamycin on days 2 and 30. 3/7 patients received further cycles of chemotherapy. The median follow- up was 35 months. RESULTS: All recurrences (before RCT) were localized either in the vagina or in or directly proximal to the vaginal stump. The main side effects of RCT were hemotoxicity (grade 3: n = 3/7; grade 4: n = 4/7; neutropenic fever n = 1/7) and diarrhea (grade 3: n = 5/7). At the median follow-up (35 months), 4/7 patients had recurrences (one local recurrence; one lymph node recurrence outside the irradiated field, two distant metastases). Local control in the irradiated field was 80% +/- 18% after 3 years. Disease-free survival calculated according to Kaplan-Meier was 57% +/- 19% after 3 years. Presently, 5/7 patients are still alive, corresponding to a 3-year survival rate of 83% +/- 15%. CONCLUSION: Concurrent RCT shows good local effectiveness with a good long-term survival. Further evaluation in phase II studies is recommended.     

Comparison of radiochemotherapy alone to surgery plus radio(chemo)therapy for non-metastatic stage III/IV squamous cell carcinoma of the head and neck

Background and Purpose

The standard treatment for non-metastatic stage III/IV squamous cell carcinoma of the head and neck varies worldwide. This study compared the outcomes of radiochemotherapy alone to surgery followed by radio(chemo)therapy (radiotherapy plus/minus concurrent chemotherapy).

Patients and Methods

Data from 148 patients treated with radiochemotherapy alone were matched to 148 patients treated with surgery plus radio(chemo)therapy. Groups were matched 1:1 for nine potential prognostic factors including age, gender, performance status, tumor site, histologic grade, T category, N category, AJCC stage, and hemoglobin level before radiotherapy, and compared for locoregional control, metastases-free survival, and overall survival.

Results

Locoregional control rates at 1, 2, and 3 years were 81%, 73%, and 67% after surgery plus radio(chemo)therapy and 81%, 74%, and 65% after radiochemotherapy alone (p = 0.89). Metastases-free survival rates were 86%, 80%, and 75% after surgery plus radio(chemotherapy) versus 87%, 80%, and 72% after radiochemotherapy alone (p = 0.57). Overall survival rates were 80%, 64%, and 63% after surgery plus radio(chemo)therapy versus 83%, 68%, and 60% after radiochemotherapy alone (p = 0.96). On multivariate analyses, T category (p < 0.001), N category (p = 0.004), and hemoglobin level prior to radiotherapy (p < 0.001) were associated with locoregional control. Histologic grade (p = 0.045), T category (p < 0.001), N category (p = 0.003), and hemoglobin level prior to radiotherapy (p < 0.001) were associated with metastases-free survival. Histologic grade (p = 0.030), ECOG perfor-mance status (p = 0.033), T category (p = 0.007), N category (p = 0.024) and hemoglobin level before radiotherapy (p < 0.001) were associated with overall survival.

Conclusion

Outcomes of radiochemotherapy alone appeared similar to those of surgery plus radio(chemo)therapy. Randomized trials comparing both treatments for different tumor sites are warranted.     

Neoadjuvant Radiochemotherapy and Radical Resection for Advanced Squamous Cell Carcinoma of the Oral Cavity

BACKGROUND AND PURPOSE: Several multimodal strategies have been developed to treat patients with squamous cell carcinoma of the oral cavity. The advantages of preoperative radiochemotherapy are downstaging of the primary tumor, an increased resectability rate, and the elimination of micrometastases. After successful phase II trials, the following therapy regimen for resectable advanced oral carcinoma was applied. PATIENTS AND METHODS: 134 patients with resectable squamous cell carcinoma of the oral cavity stage II-IV received neoadjuvant radiochemotherapy consisting of 39.6 Gy in daily fractions of 1.8 Gy and concomitant carboplatin (70 mg/m(2) days 1-5). Radical resection and neck dissection were carried out afterwards. RESULTS: After a median follow-up of 73 months, 82 patients (61%) had died. 54 patients (40%) experienced locoregional relapses or distant metastases. The overall survival was 65% +/- 4% after 2 years and 45% +/- 4% after 5 years. Cox regression survival analysis identified tumor regression, extracapsular lymph node spread and resection state as prognostic factors. Side effects of grade 3-4 were rare. CONCLUSION: Neoadjuvant radiochemotherapy with subsequent radical surgery can be recommended as an effective and safe treatment for primary resectable advanced tumors of the oral cavity. Acute and long-term toxicities appear to be moderate.     

艾迪联合长春瑞滨加顺铂方案治疗晚期非小细胞肺癌疗效观察

目的观察和评价艾迪注射液联合长春瑞滨加顺铂方案（NP方案）治疗晚期非小细胞肺癌的疗效和毒性。方法将我科近几年收治的52例晚期非小细胞肺癌患者随机分为联合治疗组和化疗组：联合治疗组采用艾迪注射液联合长春瑞滨加顺铂方案，化疗组采用长春瑞滨加顺铂方案（NP方案）。3周期化疗后进行疗效，毒性对比研究。结果联合治疗组和化疗组近期有效率分别为46％和42％，疾病进展时间（TTP）分别为6．8月和5.3月．中位生存时间分别为10．7月和9．4月，1年生存率分别为42％和38％。两组间比较差异均无显著性（P〉0．05）。联合治疗组在恶心、呕吐、骨髓抑制等毒性反应发生率方面低于化疗组，差异有显著性（P〈0．05）。结论艾迪注射液联合长春瑞滨加顺铂方案与NP方案相比．疗效相似，但毒性反应低于NP组，患者更易接受，可广泛用于临床。     

肺癌脑转移44例治疗分析

目的比较不同治疗方法对肺癌脑转移的疗效。方法对44例肺癌脑转移患者资料进行回顾性分析。根据治疗方法的不同分为单纯放疗组23例(全脑放疗10例,立体定向放疗13例),全脑放疗或立体定向放疗联合全身化疗(放疗+化疗)组17例,对症治疗组4例,比较其生存期和生存率。结果 单纯放疗组的中位生存期为8.3个月,1年生存率为17.4%;放疗+化疗组中位生存期为13.2个月,1年生存率为52.9%;对症治疗组的中位生存期为1.7个月,1年生存率为0%。放疗+化疗组比单纯放疗及对症治疗组具有更好的疗效(P<0.05)。结论放疗联合化疗是肺癌脑转移患者比较有效的治疗方法,可延长生存期。     

327例广泛期小细胞肺癌综合治疗的疗效分析

目的比较广泛期小细胞肺癌（ES-SCLC）化疗后加或不加胸部放疗的疗效,为ES-SCLC患者的综合治疗提供依据。方法回顾性分析2007年至2012年接受化疗±胸部放疗的327例初治ES-SCLC患者资料。其中,130例（39.8%）患者进行了胸部放疗（化放疗组）,197例（60.2%）接受单纯化疗（单纯化疗组）。化疗方案以EP（依托泊苷+顺铂）、CE（卡铂+依托泊苷）方案为主,胸部放疗采用调强放射治疗,放疗剂量为32~67 Gy。采用Kaplan-Meier法计算生存率,Log Rank法进行单因素预后分析,Cox回归模型进行多因素预后分析。结果全组随访率为95.1%。化疗后达完全缓解（CR）、部分缓解（PR）、稳定（SD）者分别占2.5%、76.1%和21.4%。全组中位生存时间为13.7个月,中位无进展生存时间（PFS）为9.3个月。化放疗组的生存时间和PFS均显著提高,中位生存时间为20.0个月,中位PFS为10.8个月,而单纯化疗组分别为11.4个月和7.7个月。化放疗组的2年、3年、5年总生存率（OS）分别为42.5%、27.8%、18.8%,而单纯化疗组分别为11.6%、6.6%、3.5%（χ2=50.730,P < 0.001）。亚组分析结果显示,按初诊脑转移状态和化疗疗效（CR+PR、SD）分层,胸部放疗均能显著提高OS,但不能延长初诊有脑转移的患者的PFS。胸部放疗能显著降低化放疗组的局部区域复发率至19.2%,而单纯化疗组为75.6%（χ2=100.080,P < 0.001）。结论对于化疗后无进展的ES-SCLC,胸部放疗可提高局部控制率,延长患者的总生存时间和PFS。     

Adjuvante simultane Radiochemotherapie nach operiertem Uteruszervixkarzinom in der High-Risk-Situation Ergebnisse einer Pilotuntersuchung

BACKGROUND: The most important factors for prognosis of cervical cancers are age and histological criteria such as the tumor size, the involvement of lymph nodes, lympho-vascular space involvement as well as microvessel involvement and poor tumor differentiation (grading 3). Here we present the results of concomitant chemo-radiation at high-risk situation of patients with cervical cancer after surgery. PATIENTS AND METHODS: The study comprised 34 patients with median age of 40 years (26-63 years) after Wertheim surgical technique for cervical cancer at the FIGO Stages IB (n = 19) and IIB (n = 15). All patients were treated between November 1995 and June 1999 by a schedule of concomitant chemoradiation. The indication for this treatment was given by the positive histological proof of lymph node metastasis, microvessel or lympho-vascular space involvement as well as a G3 grading. The chemo-therapy was given in week 1 and 5 (day 1-5 and day 29-33). The dosage of cisplatin was 20 mg/m2/d on every day and 5-FU was given as a 120-h infusion with 600 mg/m2/d. The external beam radiotherapy was applied to the pelvis with 1.8 Gy per fraction up to 50.4-54 Gy. In two patients the paraaortal region was irradiated too because of the involvement of these lymph nodes. RESULTS: The median observation time was 48 months (3-68 months). 30 patients are alive (88%) in complete response. Four patients died. The mean survival was 61 +/- 3 months. We have seen only slight acute toxicities of grade 1 and 2. Three patients suffered from a grade 3 diarrhea and three patients developed a grade 3 leukopenia. In seven patients we found a secondary lymphedema as a late toxicity. CONCLUSION: The concomitant chemoradiation containing cisplatin in high-risk situation for cervical cancer after surgery improves the outcome and survival in these patients.     

Radiotherapy alone or radiochemotherapy with platin derivatives following transurethral resection of the bladder

Purpose

Multivariate analysis of prognostic factors influencing survival and bladder preservation after radiochemotherapy for bladder cancer following transurethral resection of the bladder (TURB)

Patients and Methods

At the University Hospital of Erlangen 333 patients with bladder cancer were treated with either radiotherapy alone (RT, n=128) or platin based radiochemotherapy (RCT, n=205) after TURB between 5/1982 and 5/1996. Two-hundred and eighty-two curative patients, with either muscle invasive or T1-high risk cancer, were analyzed. Median age was 66 years, median follow-up is 7.5 years. Uni- and multivariate analysis was performed for age, grade, R-status after initial TURB, T-category and treatment modality relevant to the endpoints initial response, survival and bladder preservation.

Results

Treatment related mortality was below 1%. Complete remissions were achieved at 57%, 70%, and 85% after RT or RCT with carbo- or cisplatin. This difference was multivariately significant. Further significant prognostic factors were pT-category and R-status. For all patients survival was 59% and 43% after 5 and 10 years. 79% of survivors could keep their own bladder. Five-year survival rates after RT alone, RCT with carbo- or cisplatin were 47%, 57%, and 69%, respectively. This was univariately significant. The only multivariately significant factor for survival and bladder preservation was the R-status after initial TURB.

Conclusions

Treatment of bladder cancer by TURB and RT/RCT is an alternative to primary cystectomy. The addition of chemotherapy leads to significantly more complete remissions and better survival. Initial TURB is recommended to be as radical as possible.