A randomized clinical trial of radiation therapy versus thermoradiotherapy in stage IIIB cervical carcinoma

To clarify the role of thermoradiotherapy for FIGO Stage IIIB cervical carcinomas, both the clinical response and survival of patients treated with radio- or thermoradiotherapy were investigated. Forty patients with Stage IIIB uterine cervix carcinoma were treated with external beam irradiation to the pelvis, combined with iridium 192 high-dose-rate intracavitary brachytherapy. All patients were divided randomly into the following two groups: the radiotherapy (RT) group of 20 patients, who underwent radiotherapy alone; and the thermoradiotherapy (TRT) group of 20 patients, who underwent three sessions of hyper-thermia in addition to radiotherapy. The primary endpoint of this study was local complete response and survival. A complete response was achieved in 50% (10 of 20) in the RT group versus 80% (16 of 20) in the TRT group (p = 0.048). The 3-year overall survival and disease-free survival of the patients who were treated with TRT (58.2 and 63.6%) were better than those of the patients treated with RT (48.1 and 45%), but these differences were not significant. The 3-year local relapse-free survival of the patients who were treated with TRT (79.7%) was significantly better than that of the patients treated with RT (48.5%) (p = 0.048). TRT, as delivered in this trial, was well tolerated and did not significantly add to either the relevant clinical acute or long-term toxicity over radiation alone. TRT resulted in a better treatment response and 3-year local relapse-free survival rate than RT for patients with FIGO Stage IIIB cervical carcinoma.     

A randomized clinical trial of radiation therapy versus thermoradiotherapy in stage IIIB cervical carcinoma.

To clarify the role of thermoradiotherapy for FIGO Stage IIIB cervical carcinomas, both the clinical response and survival of patients treated with radio- or thermoradiotherapy were investigated. Forty patients with Stage IIIB uterine cervix carcinoma were treated with external beam irradiation to the pelvis, combined with iridium 192 high-dose-rate intracavitary brachytherapy. All patients were divided randomly into the following two groups: the radiotherapy (RT) group of 20 patients, who underwent radiotherapy alone; and the thermoradiotherapy (TRT) group of 20 patients, who underwent three sessions of hyperthermia in addition to radiotherapy. The primary endpoint of this study was local complete response and survival. A complete response was achieved in 50% (10 of 20) in the RT group versus 80% (16 of 20) in the TRT group (p = 0.048). The 3-year overall survival and disease-free survival of the patients who were treated with TRT (58.2 and 63.6%) were better than those of the patients treated with RT (48.1 and 45%), but these differences were not significant. The 3-year local relapse-free survival of the patients who were treated with TRT (79.7%) was significantly better than that of the patients treated with RT (48.5%) (p = 0.048). TRT, as delivered in this trial, was well tolerated and did not significantly add to either the relevant clinical acute or long-term toxicity over radiation alone. TRT resulted in a better treatment response and 3-year local relapse-free survival rate than RT for patients with FIGO Stage IIIB cervical carcinoma.     

Bax and Bcl-2 protein expression following radiation therapy versus radiation plus thermoradiotherapy in stage IIIB cervical carcinoma

BACKGROUND: The relative amounts of Bcl-2 and Bax proteins determine cell survival or death following an apoptotic stimulus. To clarify the molecular mechanism of cell death after radiotherapy or thermoradiotherapy and its relation to the response of AJCC/UICC Stage IIIB cervical carcinomas, the expression of Bax and Bcl-2 proteins was investigated both before and in the course of treatment given during this study. METHODS: Thirty-seven patients with Stage IIIB carcinoma of the uterine cervix were treated with external beam irradiation to the pelvis combined with iridium-192 high-dose-rate intracavitary brachytherapy. All patients were randomized to one of the following two groups: the radiotherapy (RT) group of 19 patients who were given radiotherapy alone, and the thermoradiotherapy (TRT) group of 18 patients who were given 3 sessions of hyperthermia in addition to RT. Specimens of the cervical tumors were obtained by punch biopsy both before and in the course of the treatment (after a total dose of 10.8 grays ?Gy for the RT group or after 10.8 Gy plus 1 session of hyperthermia for the TRT group). The tumor sections were stained with anti-Bax and anti-Bcl-2 monoclonal antibody. On the basis of the percentage of immunopositive cells, both pretreatment and posttreatment samples were scored. Furthermore, relative changes in protein expression were determined by comparing the pretreatment scores with those in the course of treatment. In addition, treatment response was evaluated. RESULTS: A complete response was achieved in 52.6% (10 of 19) of the RT group versus 83. 3% (15 of 18) of the TRT group (P = 0.049). Better tumor control was accompanied by increased Bax expression, i.e., 10.5% (2 of 19) of the RT group versus 44.4% (8 of 18) of the TRT group (P = 0.02). The respective number of patients who partially responded (PR) or did not respond to treatment (NC) was 26.3% (5 of 19) and 21.1% (4 of 19) of the RT group versus 11.1% (2 of 18) and 5.6% (1 of 18) of the TRT group (P = 0.2 for both the PR and NC subgroups). CONCLUSIONS: TRT was found to result in better treatment responses than RT for patients with Stage IIIB cervical carcinoma. An additive or synergistic antitumor effect of TRT is likely to occur through induction of apoptosis involving one of the bax pathways.     

A randomized trial of chemotherapy followed by pelvic radiation therapy in stage IIIB carcinoma of the cervix.

Because of the poor results in stage III B carcinoma of the cervix with standard treatment using radiotherapy alone, we designed a randomized trial to determine whether administration of chemotherapy before pelvic irradiation would improve survival. Between May 1984 and August 1986, 107 patients with previously untreated squamous cell carcinoma were randomly assigned, after stratification by age (less than 50 v greater than 50 years), extent of parametrial involvement (unilateral v bilateral), and lymphangiographic findings (negative v positive) to pelvic radiotherapy (RT; arm A) or three cycles of chemotherapy (CT; bleomycin, vincristine, mitomycin, and cisplatin [BOMP]), followed by the same radiotherapy regimen (CT + RT; arm B). The groups were balanced by age, performance status, extent of parametrial involvement, bulkiness of cervical disease, nodal involvement, and presence of hydronephrosis. Minimal follow-up is 34 months. A complete local response was observed in 32.5% of the patients in arm A and in 47% of the patients in arm B (P = .19). Overall 5-year survival rates were 39% for the RT arm and 23% for the CT + RT approach (P = .02). Toxicity was severe in arm B and included fatal pulmonary toxicity in four patients. Locoregional and distant failures were similar in both groups. We conclude that, despite a satisfactory response rate, neoadjuvant BOMP chemotherapy adversely affects survival in stage III B cervical cancer and is associated with unacceptable toxicity.     

EXPERIMENTAL AND CLINICAL STUDY OF CONCOMITANT RADIATION THERAPY AND CHEMOTHERAPY FORCERVICAL CARCINOMA

ＥＸＰＥＲＩＭＥＮＴＡＬＡＮＤＣＬＩＮＩＣＡＬＳＴＵＤＹＯＦＣＯＮＣＯＭＩＴＡＮＴＲＡＤＩＡＴＩＯＮＴＨＥＲＡＰＹＡＮＤＣＨＥＭＯＴＨＥＲＡＰＹＦＯＲＣＥＲＶＩＣＡＬＣＡＲＣＩＮＯＭＡ￥ＷｅｉＫｅ；魏克；ＣａｉＳｈｕｍｏ；蔡树模；ＷａｎｇＸｉａｎｇ－...     

Complete resolution of stage IIIB juvenile nasopharyngeal angiofibroma with radiation therapy

Juvenile nasopharyngeal angiofibroma is a benign, locally aggressive, vascular tumour of adolescent males. Extension to intracranial cavity is not uncommon and presents difficulties in management. Here we report a patient who had Radkowsky stage IIIB lesion, with blood supply from internal carotid artery. In view of anticipated problems with surgery, the patient was treated with 30 Gy in 15# external beam radiotherapy. On follow up, tumour was noted to disappear gradually overtime and at 3 years complete disappearance was noted with normal return of vision. Hence we are re-affirming the earlier studies than angiofibroma mass regresses gradually after completion of radiotherapy. Radiotherapy is a useful way of treating angiofibroma with significant intracranial extension.     

Split-course radiation therapy of carcinoma of the nasopharynx: Results of a national collaborative clinical trial of the radiation therapy oncology group

This is a report on the initial results of a Radiation Therapy Oncology Group (RTOG) prospective randomized collaborative therapeutic trial of split-course radiotherapy in carcinoma of the nasopharynx. The split-course therapy consisted of two irradiation courses, each delivering 3000 rad in 2 weeks, in 10 fractions of 300 rad. The courses were separated by a rest period of 3 weeks. Continuous radiation therapy consisted of 30 fractions of 220 rad (with an option of 2:00 rad) each, for a total dose of 6600 rad. One hundred and nine patients were eligible for analysis with a minimal follow-up period of 1 year. No statistically significant differences were observed in the two therapeutic groups, with regard to acute toxicity (normal tissue reactions, completion of therapy, and need of hospitalization during radiotherapy), late toxicity, incidence of distant metastases, patients who became free of clinically detectable tumor in the primary and neck sites at last follow-up or at death, and survival after therapy.     

30例Ⅰ期非小细胞肺癌三维适形放疗结果分析

目的 评价放弃选择性区域淋巴结照射的三维适形放疗Ⅰ期非小细胞肺癌的毒性和疗效.方法 30例经病理组织学和（或）细胞学确诊的Ⅰ期非小细胞肺癌患者接受三维适形放疗,分割剂量3～6Gy/次,5次/周,放疗总量DT63～72Gy.靶区仅包括肿瘤原发灶.结果 总有效率为97%.1、2、3年局部控制率分别为73%、60%、53%.1、2、3年生存率分别为72%、56%、52%.随访满5年的12例,5年生存率为35%.未出现3级以上放射性肺炎和放射性食管炎.3例在随访期间出现选择性淋巴结失败.结论三维适形放疗非手术的Ⅰ期非小细胞肺癌安全、有效,近期疗效满意,远期疗效需要进一步观察.放弃选择性区域淋巴结照射并没有明显增加区域淋巴结的复发率.     

Long-term outcome after radiotherapy for FIGO stage IIIB and IVA carcinoma of the cervix

PURPOSE: To report the long-term outcome after radiotherapy with curative intent for Stage IIIB and IVA carcinoma of the cervix. METHODS AND MATERIALS: We retrospectively reviewed 91 patients treated with radiotherapy with curative intent at the University of Florida between January 1980 and December 2003 for Stage IIIB (84 patients) or IVA (7 patients) carcinoma of the cervix. RESULTS: The median follow-up of the surviving patients was 8.8 years. The 5- and 10-year estimates of local control, regional control, locoregional control, relapse-free survival, and overall survival were 53% and 53%, 55% and 47%, 34% and 29%, 30% and 26%, and 29% and 21%, respectively. Ninety percent of the recurrences occurred within 2 years of treatment. Of these, 60% of all failures were local, 29% were regional, and 11% were distant failures alone. Also, 17% of the failures were in the paraaortic nodes with no evidence of failure in the pelvis. Univariate and multivariate analyses were conducted with the endpoint of relapse-free or overall survival. No factor was statistically significant. Complications from therapy were scored using the Radiation Therapy Oncology Group grading system; the overall severe late complication rate was 13% (Grade 3-5). CONCLUSION: This series is one of the most mature of published reports. With long-term follow-up, approximately one-third of patients with Stage IIIB or IVA carcinoma of the cervix were cured, with a 13% complication rate.     

盐酸伊立替康对局部晚期宫颈癌放射增敏的临床研究

目的：探讨盐酸伊立替康对局部晚期宫颈癌的放射增敏作用及毒副反应。方法．41例经病理确诊的局部晚期宫颈癌患者（ⅡB～ⅣA期）随机分为两组：单纯放疗组21例，给予常规根治性放疗；增敏组20例，常规根治性放疗＋伊立替康，在放疗后1h内给予伊立替康40mg／m^2，静滴，每周1次，放疗第1天开始，共用5周。观察两组的宫颈局部肿瘤消退50％所需时间（T钟）、近期疗效（局部控制率）及毒副反应。结果：增敏组的T50为10．5天，单纯放疗组的T50为15天，两者比较有显著性差异（P〈0．05）；增敏组局控率为85．0％（17／20），单纯放疗组局控率为52．4％（11／21），两者比较差异显著（χ^2=5．02，P=0．025）。伊立替康增敏组胃肠道反应较单纯放疗组发生率高，但多为Ⅰ～Ⅱ度反应，未见Ⅳ度反应，其他的毒副反应在两组间差异无统计学意义。结论：在局部晚期宫颈癌中，低剂量盐酸伊立替康与放疗联合使用可使肿瘤消退50％所需时间缩短，提高局部控制率，改善近期疗效，无严重毒副反应发生。     

放疗合并化疗治疗晚期宫颈癌的疗效观察

对60例晚期宫颈癌患者分别采用常规根治量放疗加VPB方案化疗（治疗组）和单行根治量放疗（对照组）、结果表明：治疗组患者的宫颈局部肿瘤缩小和消失时间校对照组明显缩短,宫颈局部肿瘤缩小50％所需放射剂量亦校对照组减少;治疗组未出现严重毒性反应,患者对治疗耐受性良好。     

Split-course versus continuous pelvis irradiation in carcinoma of the uterine cervix: a prospective randomized clinical trial of the Radiation Therapy Oncology Group

In August 1980, the Radiation Therapy Oncology Group (RTOG) completed a prospective randomized clinical trial for the comparison of a split-course versus a standard continuous course of pelvic irradiation for carcinoma of the uterine cervix Stages II-B, III-A, III-B, and IV-A. The split-course consisted of 10 fractions of 250 rad each, 5 times a week, up to 2500 rad followed by a rest period of approximately 2 weeks and then another 2500 rad was given (250 X 10). The continuous course consisted of 30 fractions of 170 rad each, 5 times per week, for a total of 5100 rad. In both groups the external pelvis irradiation was followed by intracavitary brachytherapy in the uterus and vagina, with tandem-colpostat or tandem only, for a dose of 3000 rad at point A for the former, or at 2 cm from the center of the linear source for the latter. In cases where brachytherapy was not possible, a boost of external irradiation with reduced field, with a dose of 1600 rad (200 X 8) was advised. Three hundred and one patients were registered, of which 287 are currently evaluable. No differences between the treatments were detected for the following study end-points: treatment tolerance in terms of acute normal tissue reactions and completion of therapy, tumor control in the pelvis, severe late normal tissue reactions, and survival. In the entire study population the estimated tumor control in the pelvis at two years after initiation of therapy was: 81% for Stage II-B, 67% for III-A, 53% for Stage III-B, and 32% for Stage IV-A. The estimated two-year survival was: 70% for Stage II-B, 58% for III-A, 46% for III-B, and 23% for IV-A.     

A phase I study of carboplatin concurrent with radiation in FIGO stage IIIB cervix uteri carcinoma

PURPOSE: Chemoradiation based on cisplatin, most commonly weekly, is the standard treatment of locally advanced cervical cancer; however, the nephrotoxic potential and the requirement for hydration of cisplatin somewhat restrains its use. The objective of this study was to determine the recommended dose of carboplatin when administered weekly during pelvic radiation (RT). METHODS AND MATERIALS: Twenty-four histologically proven, International Federation of Gynecology and Obstetrics Stage IIIB patients were treated with standard pelvic RT concurrently with six weekly applications of carboplatin at the following dose levels: 100 mg/m(2), 116 mg/m(2), 133 mg/m(2), and 150 mg/m(2). Six patients per level were treated. Acute toxicity was assessed according to the Radiation Therapy Oncology Group Acute Radiation Morbidity Scoring Criteria. The recommended dose was defined as the one that was one level below the level at which dose-limiting toxicity was present in more than one-third of patients. RESULTS: Between September 2001 and July 2002, 24 patients were accrued. All but two completed external beam radiotherapy and intracavitary treatment. The treatment was well tolerated. The median number of weekly applications of carboplatin was six, and the mean dose to points A and B was 85.6 Gy (range 75.2-91.6) and 62.9 Gy (range 58.2-74.6), respectively. RT was delivered within 41.7 days (range 33-70). Dose-limiting toxicity (leukopenia and/or neutropenia) was present in 50% of patients treated at the higher dose level (150 mg/m(2)). At the recommended dose of 133 mg/m(2), 33% of patients presented with Grade 3 leukopenia. At treatment completion, 75% of patients had a complete clinical response. CONCLUSION: Carboplatin at 133 mg/m(2), weekly for 6 weeks, is a well tolerated and effective radiosensitizer in cervical cancer patients.     

培美曲塞+顺铂或多西他赛+顺铂同期胸部IMRT治疗Ⅳ期肺腺癌的疗效和安全性

目的 探讨培美曲塞+顺铂(PP)或多西他赛+顺铂(DP)同期胸部调强放疗(IMRT)治疗晚期肺腺癌的临床疗效和毒副作用。方法 将2011年—2016年1月贵州省肿瘤医院收治的EGFR突变未知或野生型的Ⅳ期肺腺癌随机分为PP组(50例)和DP组(51例)。2组患者均接受同期胸部IMRT,处方剂量60~70 Gy。主要研究终点为1年生存率,次要研究终点为不良反应。结果 PP组和DP组的总有效率(CR+PR)分别为68%和72%(P=0.617);中位生存时间分别为19.6个月(95%CI:13.9~25.3)和12.1个月(95%CI:10.7~13.5);1、2、3年生存率分别为72.0%、28.0%、16.0%和52.9%、17.6%、13.7%(P=0.049)。PP组和DP组3—4级白细胞分别下降48%和63%(P=0.098);3—4级粒细胞分别减少34%和65%(P=0.002);3-4级血红蛋白发生率分别为38%和10%(P=0.024);3—4级血小板分别降低为40%和14%(P=0.003)。2组患者2级急性放射性肺炎(P=0.625)和3级放射性食管炎(P=0.484)发生率相似,无≥3级的放射性肺炎及≥4级的放射性食管炎。结论 培美曲塞+顺铂治疗晚期肺腺癌同期放化疗的疗效优于多西他赛+顺铂,急性放射性食管炎与肺炎相似,血液学不良反应各有优势,患者可耐受。临床试验注册 中国临床试验注册中心(ChiCTR-TRC-13004184)。     

早期鼻咽癌单纯外照射与加近距离治疗的远期结果比较

目的随机比较单纯常规外照射与外照射加近距离治疗对早期鼻咽癌原发灶的局部控制疗效和并发症。方法对126例初治的、福州分期为T1期和部分12期(口咽、颈动脉鞘、椎前软组织受侵者除外)鼻咽癌病例进行前瞻性分组。单纯常规外照射组(RT)61例，外照射加^192Ir高剂量率近距离治疗组(RB)65例。26例T1期在疗前经抽签随机接受单纯外照射66～70Gv或外照射56Gv加近距离治疗10～16Gy，1～2次(中位剂量16Gy)；100例12期先采用常规外照射至50Gy后，行CT或MRI检查，对咽旁间隙消退满意的病例入组随机接受单纯外照射(中位剂量72Gv)或外照射(中位剂量66Gy)加近距离治疗8～24Gy，1～3次(中位剂量16Gy)。近距离治疗在外照射结束后1周进行，剂量参考点距施源器中心轴的距离为7～12mm，单次近距离照射剂量为5～8Gy／周。结果外照射结束时RT组鼻咽病灶残留6例，消退55例；RB组残留13例，?肖退46例，未评价6例。RT组鼻咽部失败8例，RB组鼻咽部失败7例(包括单独颅底失败2例)。5年鼻咽(颅底)局部控制率RT组为86％，RB组为88％。5年总生存率RT组为83％，RB组为84％(P=0．84)。放射性脑病RT组为10例(1级4例，2级6例)，RB组为7例(1级4例，2级3例)。张口困难发生率RT组明显高于RB组(26％：10％，P=0．02)。结论对早期鼻咽癌行计划性外照射加腔内近距离治疗，能获得与单纯常规外照射相近的局部控制率及总生存率，并降低外照射剂量和减低张口困难的发生率。     

宫颈癌IB1、IB2期的临床回顾性分析

目的 分析宫颈癌分期中ＩＢ１、ＩＢ２期的治疗结果以及淋巴结转移、宫颈间质浸润、组织分级与预后的关系。方法 ３５６例ＩＢ期宫颈癌全部行广泛性子宫切除和盆脸淋巴清除术,７２例辅以术前放疗（ＩＢ１期３９例,ＩＢ２期３３例）,８３例行术后放疗（ＩＢ１期６１例,ＩＢ２期２２列１例行术前,术后放疗（ＩＢ２期５例,ＩＢ２期６例）。结果 随访５年以上者２４９例,总的５年存活率６９．９％,ＩＢ１期为７３．３％（１８     

官颈癌治疗后主动脉旁淋巴转移调强放疗剂量学研究及临床观察

目的：探讨调强放射治疗（intensity modulated radiotherapy,IMRT）应用于宫颈癌治疗后主动脉旁淋巴结转移的剂量学特点、治疗效果及在减少并发症方面的价值。方法：选取2005—06—01—2012—12—30临沂市肿瘤医院（65例）和山东省肿瘤医院（51例）接受全程IMRT或适形放疗（conventional radiotherapy,CRT）治疗的116例主动脉旁淋巴结转移的宫颈癌患者。56例宫颈癌治疗后主动脉旁淋巴结转移患者接受全程IMRT,给予PTV剂量（58～69）Gy／（29～30）次,2．0～2．3Gy／次,中位剂量63．5Gy,随机选择10例患者,用三维治疗计划系统进行IMRT和常规放疗（CRT）计划设计,拟给予相同的处方剂量,比较危及器官受照射剂量。随机选择同期接受CRT（60例）患者,比较IMRT和CRT的靶区剂量、疗效、急性和晚期毒副作用及生存率。结果：56例患者均完成全程IMRT,95％的等剂量曲线可以覆盖99％的PTV体积,IMRT与拟行CRT计划比较,IMRT计划中小肠（t=2．958,P=0．016）、肾脏（t=14．438,P〈0．001）和脊髓（t=34．511,P〈0．001）受照射剂量明显降低,靶区剂量明显提高,t=20．924,P〈0．001,IMRT组的急性和慢性毒副作用均明显减少,P〈0．05。两组完全缓解率（x2=11．048,P=0．001）、部分缓解率（x2=5．893,P=0．015）和总有效率（x2=32．251,P〈0．001）比较差异均有统计学意义;1、3和5年生存率比较差异有统计学意义,x2=9．530,P=0．002。结论：IMRT对宫颈癌治疗后主动脉旁淋巴结转移患者可获得理想的剂量分布,邻近危及器官得到保护,临床疗效满意,毒副作用明显减少,有效率提高,生存期明显延长。     

同步放化疗和单纯放疗治疗ⅡB～ⅢB期宫颈癌的疗效比较

背景与目的:同步放化疗已成为局部晚期宫颈癌的标准治疗模式,但对于放疗联合何种方案的化疗效果最佳,目前尚无一致意见.本研究中我们比较同步放化疗与单纯放疗,以及同步放化疗不同化疗方案的疗效及毒副反应.方法:2003年1月至2004年12月江西省妇幼保健院收治的符合人组标准的ⅡB～ⅢB期宫颈癌患者285例,按住院序号随机分为单纯放疗组142例,同步放化疗组143例.同步放化疗组又按化疗方案不同分为:BP(博来霉素 顺铂)方案同步放化疗51例,TP(紫杉醇 卡铂)方案同步放化疗47例,FP(氟尿嘧啶 顺铂)方案同步放化疗45例.比较单纯放疗组与同步放化疗组患者的3年生存率和不良反应,同时对同步放化疗三种不同化疗方案组的3年生存率及不良反应进行比较.结果:全组中位随访时间为42个月,单纯放疗组与同步放化疗组的3年生存率分别为65%和75%,两组比较差异有统计学意义(P=0.042).单纯放疗组Ⅲ～Ⅳ度急性毒副反应低于同步放化疗组(P<0.001),迟发性毒副反应两组差异无统计学意义(P=0.613).同步放化疗组BP方案、TP方案、FP方案的3年生存率分别为74%、80%和71%,三组间比较差异无统计学意义(P=0.792).三组Ⅲ～Ⅳ度急性及迟发性毒副反应发生率相似.结论:与单纯放疗相比,同步放化疗可明显提高ⅡB～ⅢB期宫颈癌患者的疗效.在同步放化疗三种不同的化疗方案中,紫杉醇联合卡铂方案组患者3年生存率略高于其他两种化疗方案,毒副反应可耐受,值得进一步研究.     

A randomized trial comparing radiation therapy versus concomitant radiation therapy and chemotherapy in carcinoma of the thoracic esophagus.

From September 1982 to December 1985, 59 previously untreated patients with Stage II squamous cell carcinoma of the thoracic esophagus were randomly assigned to receive radiation therapy (RT) alone versus the concomitant use of RT and chemotherapy (CT) with 5-fluorouracil (5-FU), mitomycin C, and bleomycin (RT + CT). Thirty-one patients were randomized to the RT regimen and 28 to the RT + CT regimen. The complete local response rate was 58% for the RT group and 75% for the RT + CT group (P = 0.77). The median duration of response was 8 months for both groups. The overall 5-year survival rates were 6% and 16% (P = 0.16) for the RT and RT + CT groups, respectively. Acute toxicities were more pronounced in the RT + CT group. This clinical trial did not detect a difference in outcome with combined-technique therapy. This result must be interpreted with caution because of the small number of patients entered in this trial. Confirmation of the value or lack of value for combined therapy will require additional larger clinical trials.     

Hydroxyurea plus pelvic radiation versus placebo plus pelvic radiation in surgically staged stage IIIB cervical cancer

Forty-five evaluable patients with stage IIIB carcinoma of the uterine cervix were entered into a prospective, double-blind, randomized study to evaluate the possible radiation-potentiating properties of hydroxyurea. All patients were documented to be without para-aortic lymph node metastasis by pretherapy staging para-aortic lymphadenectomy. The original plan of therapy was for continuous therapy (200 rads/day) of 6,000 rads of pelvic radiation for 6 weeks plus intrauterine radium. However, 16 patients received 6,000 rads in 8 weeks by split-course therapy (2-week rest after 3,000 rads) plus radium. Twenty-nine patients received the planned continuous therapy. The median dose of pelvic radiation for patients who received continuous therapy or split-course radiation was 6,000 rads. Leukopenia (WBC less than 2,500/mm3) was significantly increased in the patients given hydroxyurea as compared to those given placebo (P less than .001). There was no statistically significant difference relative to anemia, thrombocytopenia, radiation skin reaction, diarrhea, or radiation-induced complications requiring surgical correction. The estimated 5-year progression-free survival rate for the combined, continuous, and split-course radiation therapy hydroxyurea patients was 60%, and its was 52% for the corresponding placebo patients (P = .49). However, the estimated 5-year progression free survival rate for the correctly treated patients (continuous therapy) was 91% for the hydroxyurea group and 60% for the placebo group (P less than .06).