Phase I study of alternating doublets of topotecan/carboplatin and paclitaxel/carboplatin in patients with newly diagnosed, advanced ovarian cancer.

OBJECTIVE: The aim of this study was to evaluate topotecan with carboplatin in an alternating doublet with carboplatin and paclitaxel in first-line ovarian cancer. METHODS: Patients with newly diagnosed stage III/IV ovarian cancer were studied. The maximum tolerated dose (MTD) of topotecan (cycles 1, 3, 5, 7) in an alternating doublet regimen was determined through standard dose escalation in cohorts of three; doses of carboplatin (area under the curve [AUC] 4 to 5) and paclitaxel (175 mg/m(2), cycles 2, 4, 6, 8) were fixed. Dose-limiting toxicity (DLT) was defined only for cycle 1 as febrile neutropenia, prolonged grade 4 granulocytopenia, grade 4 thrombocytopenia, > or =grade 3 nonhematologic toxicity, or failure to recover in < or =7 days. The use of granulocyte colony-stimulating factor (G-CSF) to permit further dose escalation was also studied. RESULTS: Thirty-seven patients received 142 cycles of topotecan/carboplatin. Hematologic DLTs included grade 4 neutropenia (59 events, 42% of cycles) and thrombocytopenia (32 events, 23% of cycles). Granulocytopenia was generally short-lived, and only 2 cases of febrile neutropenia occurred. The MTD was 1.0 mg/m(2)/day topotecan and carboplatin AUC 4, alternating with 175 mg/m(2) paclitaxel and carboplatin AUC 4. Although G-CSF effectively managed myelosuppression, thrombocytopenia developed in later cycles, limiting further topotecan dose escalation. The median progression-free survival was 20.5 months, and elevated pretreatment CA-125 levels normalized in 29 of 34 (85%) patients. CONCLUSION: The establishment of a reasonably well-tolerated alternating doublet regimen, coupled with evidence of antitumor activity, provides the basis for further investigation of topotecan in first-line therapy of ovarian cancer. Topotecan (1.0 mg/m(2) daily for 3 days) was chosen for further evaluation in a phase II study.

A phase I/II dose escalation study of carboplatin in the treatment of newly diagnosed patients with advanced ovarian cancer receiving paclitaxel.

The objective of this study was to determine the maximum tolerated dose of carboplatin when administered with paclitaxel in previously untreated patients with ovarian cancer. Patients were treated with paclitaxel at 225 mg/m2 for 3 hours followed by carboplatin at an area under the curve (AUC) of 6, 7, 8, or 9 every 3 weeks. Granulocyte colony-stimulating factor was added if needed to maintain dose intensity before dose reductions were used for grade 4 hematologic toxicity or febrile neutropenia. Twenty-two patients were enrolled in the study. At the AUC 6 level, five of six patients finished all six cycles. At the AUC 7 level, four of five patients completed six cycles, although three required dose reductions for toxicity. At the AUC 8 level, all four patients completed six cycles and two required dose reductions. The AUC 9 level was not well tolerated. Only four of seven patients completed six cycles. Neutropenia was common, and transient thrombocytopenia was more severe and required dose reduction, especially in later cycles. An AUC of 8 is the maximum tolerated dose of carboplatin in combination with paclitaxel at 225 mg/m2 for 3 hours.

Phase I dose escalation of paclitaxel in patients with advanced ovarian cancer receiving cisplatin: rapid development of neurotoxicity is dose-limiting.

PURPOSE: To determine the maximum-tolerable dose (MTD) of paclitaxel in a phase I dose-escalation study when combined with cisplatin in patients with advanced ovarian cancer receiving filgrastim for prophylaxis of myelosuppression. PATIENTS AND METHODS: A total of 23 patients with stage II (bulky residual), III, or IV epithelial ovarian cancer were treated (following debulking surgery) with paclitaxel as a 3-hour infusion followed by cisplatin (75 mg/m2) administered over 4 hours on day 1, repeated every 21 days for six cycles. Filgrastim (5 micrograms/kg/d) was administered subcutaneously (SC) beginning on day 2 of each cycle through neutrophil recovery (absolute neutrophil count [ANC] > 10,000/microL). Patients were assigned to one of six escalating dose levels of paclitaxel: 150 (n = 3), 175 (n = 3), 200 (n = 3), 225 (n = 4), 250 (n = 4), and 275 mg/m2 (n = 6). RESULTS: At each paclitaxel dose level (150, 175, 200, 225, 250, and 275 mg/m2), the numbers of patients who completed six cycles without dose reduction were three (100%), three (100%), two (66%), two (50%), three (75%), and zero (0%), respectively. The numbers of patients who experienced a grade III/IV adverse event (hematologic or nonhematologic) were zero (0%), two (66%), two (66%), one (25%), four (100%), and five (80%), respectively. Reasons for dose reduction included neurotoxicity (225 mg/m2, n = 1; 275 mg/m2, n = 2), neutropenia (225 mg/m2, n = 2), diarrhea (275 mg/m2, n = 2), and nephrotoxicity (225 mg/m2, n = 1). Reasons for not completing six cycles at full or reduced dose included neuropathy (200, 225, and 275 mg/m2, n = 1 each) physician request (275 mg/m2, n = 1), and death (275 mg/m2, n = 1). Hematopoietic toxicity was minimal. Six patients developed grade III/IV neutropenia. No patient developed thrombocytopenia below a level of 50,000/microL. CONCLUSION: The MTD of paclitaxel was determined to be 225 mg/m2 when administered as a 3-hour infusion and combined with cisplatin (75 mg/m2). Nonhematologic dose-limiting toxicities were neuropathy and diarrhea. The neuropathy often had a rapid onset, especially at the higher dose levels.

Postoperative adjuvant cisplatin, doxorubicin, and cyclophosphamide (PAC) chemotherapy in women with high-risk endometrial carcinoma.

Because extrapelvic failure is common in women with high-risk endometrial carcinoma, the curative impact of adjuvant irradiation is limited. To address the issue of systemic failure, we prospectively treated 62 at-risk patients with postoperative chemotherapy between October 1985 and April 1992. Patients were considered eligible if they had grade 2 disease with mid- or outer one-third myometrial invasion, grade 3 tumor with any myometrial invasion, completely resected extrauterine disease, or variant histology (clear cell, papillary serous). Adjuvant therapy consisted of intravenous cisplatin (50 mg/m2), doxorubicin (50 mg/m2), and cyclophosphamide (500 mg/m2) given every 4 weeks for six courses. Toxicity was moderate: 31 patients (50%) had grade 3/4 neutropenia; dose reductions were mandated in 39 cases. However, there were only four hospital admissions for toxicity during 366 treatment cycles. All but three patients completed planned treatment. Recurrences have been noted in 14 of 29 patients with extrauterine disease and in 8 of 33 without. Eighteen of the 22 recurrences (82%) were outside the pelvis. At this writing, 17 patients with recurrence were dead, and 4 are alive with disease. Median time to recurrence was 13 months. Observed progression-free intervals for those with and without extrauterine disease are 26 and 36+ months, respectively, over a median follow-up period of 37 months. Actuarial 3-year survivals for those with and without extrauterine spread were 46 and 82%, respectively. Although adjuvant PAC did not prevent distant failure in women with extrauterine disease, the survival rate was greater than that anticipated for patients with disease confined to the uterus. A randomized trial comparing adjuvant irradiation to PAC is warranted in this subset.

Stage I cervical adenocarcinoma: prognostic evaluation of surgically treated patients.

In order to evaluate clinicopathologic determinants of recurrence in adenocarcinoma of the uterine cervix, a detailed retrospective chart review and complete pathology analysis were performed for 79 patients who had been treated by Type III radical hysterectomy between 1975 and 1988. All patients had clinical stage I disease; 77 had cervical diameters of 4 cm or less. Eleven patients (14%) developed recurrent disease with a median time to recurrence of 14 months (range, 7-51). Recurrence location was central in 5 patients, pelvic wall in 2, and distant in 4. Seven patients died of disease. Five-year actuarial survival was 89%. None of the clinical features examined as possible prognostic factors was predictive of recurrence, including patient age (P = 0.91), cervical diameter (P = 0.30), presence of pain (P = 0.53), presence of abnormal bleeding (P = 0.19), and history of oral contraceptive use (P = 0.58). However, univariate analysis showed lymph node spread (P = 0.008), lymph-vascular space invasion (P = 0.05), and increasing grade (P = 0.05) to be significant predictors of recurrence. Lymph-vascular space invasion remained significant when patients with positive nodes were excluded (P = 0.026). Depth of invasion > 3 mm was associated with greater recurrence risk than depth < or = 3 mm (P = 0.01). Number of mitoses (P = 0.10) was not significant. Multivariate analysis selected nodal positivity as the major prognostic parameter (P = 0.04). Further studies are needed to more clearly define the role of lymph-vascular space invasion, as an elevated risk ratio of 1.6 suggests an increased risk for recurrence. Patients whose pretreatment biopsies demonstrate obvious lymph-vascular space invasion might be considered for alternate treatment.

Treatment of advanced or recurrent squamous cell carcinoma of the uterine cervix with mitomycin-C, bleomycin, and cisplatin chemotherapy.

Fifty-nine patients with recurrent/persistent, or advanced local/metastatic squamous cell cancer of the cervix were treated with combination chemotherapy consisting of mitomycin-C, bleomycin, and cisplatin. Response to therapy and survival analysis was determined for 44 of 49 patients who had previously been treated with radiation therapy and/or surgery and for 10 patients with advanced, previously untreated disease. Seven (16%) of the 44 previously treated patients experienced either complete response (CR) or partial response (PR). The median progression-free interval for responders (CR + PR) was 14.5 months, compared with 2.6 months for the nonresponders (significant, P < 0.001). The median survival time for responders (CR + PR) was 15.9 months, compared with 5.9 months for nonresponders (significant, P < 0.01). The 10 previously untreated patients were separately evaluated for response to chemotherapy. Of these, there was 1 CR, 2 PR, 1 < PR, and 6 SD. The 3 responders (CR + PR), who subsequently underwent radiation therapy, were alive and without evidence of disease 7.9, 13.7, and 27.6 months after treatment. Toxicities were mild to moderate, with no treatment-related deaths. In this study, this combination of mitomycin-C, bleomycin, and cisplatin chemotherapy was found to have activity in local, previously untreated disease and in patients with disease recurrence outside pelvic radiation fields.

Successful treatment of refractory gestational trophoblastic neoplasm with high-dose etoposide and cyclophosphamide.

A patient with gestational trophoblastic neoplasm failed treatment with several standard chemotherapy regimens and had progressive disease with development of lung and brain metastases and a rising HCG level. Following resection of the metastases and whole-brain radiotherapy she was treated with high-dose etoposide and cyclophosphamide. She promptly attained a complete remission and remains free of disease 15 months after completion of therapy. This regimen, although initially developed for leukemia and lymphoma treatment, has potential as a therapy for refractory gestational trophoblastic neoplasm because it delivers high doses of agents very active in this disease.

Prospective treatment of advanced or recurrent endometrial carcinoma with cisplatin, doxorubicin, and cyclophosphamide.

Both single-agent cisplatin and the combination of doxorubicin and cyclophosphamide demonstrated moderate activity against endometrial carcinoma in earlier salvage trials. Since January 1979, 102 patients with advanced primary (n = 42) or recurrent (n = 60) endometrial carcinoma were prospectively treated with cisplatin (50 mg/m2), doxorubicin (50 mg/m2), and cyclophosphamide (500 mg/m2) (PAC). PAC was administered monthly until disease progression or toxicity precluded additional therapy. Patients received a median of five treatment cycles (range 1-13). Of the 87 patients with measurable disease, 12 had a complete clinical response, while 27 had a partial clinical response, for an overall objective response rate of 45%. No differences in response rates between primary and recurrent disease patients were noted. Median time to response was 2.5 months with a median response duration of 4.8 months. Nonresponders included 33 patients with stable disease and 15 with progression. Median progression-free survival for all patients was 6 months. Dose escalation was possible in 25% of patients; however, 52% of patients required dose reductions during treatment. Clinically significant toxicities included neutropenia (65%), anemia (47%), emesis (21%), nephrotoxicity (17%), and neurotoxicity (4%). Our study indicates that endometrial cancer is significantly responsive to PAC. Enthusiasm for this regimen should be tempered by the limited duration of response and substantial treatment toxicity.

Adjuvant chemotherapy with cisplatin, doxorubicin, and cyclophosphamide (PAC) for early-stage high-risk endometrial cancer: a preliminary analysis.

Between October 1985 and January 1989, 33 patients with stage I (31) or clinically occult stage II (2) endometrial cancer at a high risk for recurrence were entered in a prospective study evaluating adjuvant cisplatin, doxorubicin, and cyclophosphamide (PAC) chemotherapy. Eligibility criteria included grade 2 tumors with middle- or outer-third myometrial invasion (16), grade 3 tumors with any degree of myometrial invasion (17), presence of extrauterine disease with no gross residual (17), or a high-risk histologic subtype including papillary serous (4), adenosquamous (5), or clear cell (1) tumors. Patients received PAC (50/50/500 mg/m2) at 4-week intervals for six cycles. Thirty patients (90%) completed therapy. Toxicity included severe neutropenia in 14 patients, neutropenic sepsis in 2 patients, and doxorubicin-related cardiomyopathy in 1 patient. There were no treatment deaths. Current median follow-up is 25 months. Nine patients (27%) have developed a recurrence, 7 of whom died, after a median interval of 14 months. Eight of the 9 with recurrence initially had extrauterine disease (P = 0.02). The resulting 2-year actuarial progression-free and overall survival rates were 79 and 83%, respectively. The median progression-free interval was 29 months for patients with extrauterine disease and 45+ months for those with no extrauterine disease (P = 0.02). These results suggest that a phase 3 randomized trial comparing adjuvant PAC with radiation therapy is warranted.

Radical wide excision and selective inguinal node dissection for squamous cell carcinoma of the vulva.

Limited resection of some vulvar cancers may provide cure rates equivalent to those obtained with radical vulvectomy and bilateral inguinal node dissection. Rapid recovery, fewer complications, and better functional result have been described as advantages to less extensive procedures. Since 1978, 32 patients with invasive squamous cell cancer of the vulva (depth greater than 1 mm) and clinically negative inguinal lymph nodes underwent radical wide excisions as primary therapy. Mean age at diagnosis was 61 years. Seventeen patients had T1 and 15 had T2 tumors. Resection of the primary lesion was tailored to lesion location and size, and dissection was carried to the deep perineal fascia. Twenty-two patients had unilateral superficial inguinal lymph node dissections, five with midline lesions had bilateral superficial dissections, and five had node samplings which included deep inguinal nodes. Depth of invasion ranged from 1.5 to 13.0 mm. Mean largest lesion dimension was 23 mm. Five-year lifetable survival for the entire group was 84%. Univariate analysis of potential prognostic variables showed no significant recurrence or survival differences for patient age (P = 0.56), symptom duration (P = 0.57), FIGO stage (P = 0.67), tumor grade (P = 0.20), tumor location (P = 0.26), depth of invasion (P = 0.56), or resection margin status (P = 0.63). Thirty-one percent of patients had perioperative complications, and 16% developed delayed complications. Mean hospital stay was 10 days. Three patients (10%) developed new or recurrent vulvar disease and underwent additional therapy. None have died of disease, although one is alive with persistent tumor. Radical wide excision and selective inguinal lymphadenectomy constitute a reasonable alternative to radical vulvectomy with bilateral inguinal node dissections for squamous tumors clinically limited to the vulva. Outcome may not be strongly influenced by lesion size or depth of invasion.

Treatment of malignant germ cell tumors of the ovary with bleomycin, etoposide, and cisplatin.

Since 1984, we have treated 26 patients with malignant ovarian germ cell tumors with a combination of bleomycin, etoposide (VP-16), and cisplatin (BEP) at The University of Texas MD Anderson Cancer Center (UTMDACC). The median age of the patients was 19 years (range, 8 to 32). All patients underwent initial surgery (unilateral salpingo-oophorectomy in 14, unilateral salpingo-oophorectomy plus abdominal hysterectomy in one, and bilateral salpingo-oophorectomy with or without hysterectomy in 11 patients). Twenty patients had no residual disease, three had less than or equal to 2 cm (one each, dysgerminoma, mixed, and immature teratoma), and three had more than 2 cm lesions (two dysgerminomas, one endodermal sinus tumor). Fourteen patients had pure dysgerminoma (five, stage I; one, stage II; six, stage III; and two, recurrent), and 12 had nondysgerminomatous tumors (five, stage I; two, stage II; three, stage III; and two, recurrent). All four patients with clinically measurable disease had a complete response. All four patients who underwent second-look laparotomy had negative findings. Twenty-five patients (96%) remain in sustained remission 10.4 to 54.4 months from the start of chemotherapy. One patient died of progressive disease 14 months after beginning chemotherapy. We conclude that the BEP regimen has excellent activity and acceptable toxicity in patients with malignant ovarian germ cell tumors.

Clear cell carcinoma of the ovary: a study of 59 cases.

Clear cell carcinoma of the ovary accounts for 2 to 3% of all epithelial ovarian neoplasms. Patient profiles, pathological characteristics, and results of treatment are reviewed for 59 patients. The median age was 51. Disease extent at diagnosis was as follows: stage I, 18 patients (31%); stage II, 20 patients (34%); stage III, 15 patients (25%); stage IV, 3 patients (5%); and unknown stage, 3 patients (5%). Endometriosis was identified in 13 patients (22%). Hysterectomy and bilateral salpingo-oophorectomy were performed in 47 patients (80%), unilateral salpingo-oophorectomy in 8 patients (14%), and bilateral salpingo-oophorectomy in 4 patients (7%). Radiotherapy was given to 15 patients (25%), and chemotherapy was given to 42 patients (71%). The overall 2- and 5-year survival rates were 49 and 43%. The median survival was 26 months. Patients with tumors with fewer than 10 mitoses per 10 high-power fields and less than 50% solid areas had significantly longer disease-free intervals. Clear cell tumors are usually diagnosed at an earlier disease stage than the other epithelial ovarian cancers; stage for stage, however, the prognoses are similar.

Secondary cytoreductive surgery for recurrent epithelial ovarian cancer.

Thirty patients with recurrent epithelial ovarian carcinoma who underwent secondary tumor-reductive surgery at M. D. Anderson Cancer Center were studied retrospectively. All had been initially treated by primary reductive surgery and postoperative chemotherapy and had a period of clinical remission of at least 6 months thereafter. Ninety percent of patients had grade 2 or 3 tumors. In 17 (57%), residual tumor volume was reduced to less than 2 cm. There were no postoperative deaths, but 40% of patients suffered postoperative morbidity, mostly prolonged ileus. Median survival after second surgery was 16.3-18 months for patients with residual tumor volume less than 2 cm and 13.3 months for those with residual volume greater than 2 cm (nonsignificant). When the second surgery followed the first by less than 18 months, survival was a median of 13.5 months after the second operation as compared with 19 months when the interval was 18 months or longer (nonsignificant). Twenty-two patients received postsurgical chemotherapy; only 11% of those who were evaluable responded. Although secondary tumor-reductive surgery for recurrent ovarian cancer is technically feasible, in the absence of an efficacious second-line medical therapy, its value is limited.

High-risk metastatic gestational trophoblastic disease: further stratification into two clinical entities.

Forty-two of sixty-seven patients (62.7%) treated for high-risk metastatic trophoblastic disease achieved and maintained complete remissions. The survival rate was significantly improved in those patients with scores lower than 8 according to a modification of the World Health Organization (WHO) prognostic scoring system. A low score was associated with a higher probability of response to single-agent therapy, although the difference was not statistically significant. The score, however, was significantly associated with response to multiagent chemotherapy with methotrexate, actinomycin D, and cyclophosphamide (P = 0.0004). Therefore, future trials of new combinations of chemotherapy in high-risk patients should be stratified according to the patients' prognostic scores.

Gracilis myocutaneous vaginal reconstruction concurrent with total pelvic exenteration.

The gracilis myocutaneous vaginal reconstruction is commonly performed in patients undergoing a total pelvic exenteration. This retrospective review compares the operative and perioperative morbidity in 107 patients who underwent reconstruction with that in 44 patients who did not have reconstruction. With incorporation of the reconstructive procedure, there were no increases in operating time, blood loss, or length of hospitalization. Before 1980, 65% of patients experienced prolapse of the neovagina; in 25% it was severe. The frequency of prolapse has since been decreased to 16% (6% severe) because of several modifications to the initial technique. Modifications have included using smaller flaps, anchoring the neovagina to the levator and retropubic fascia, and, when necessary for mobilization, ligating the neurovascular pedicle. With these modifications, 66% of patients also remained free of wound breakdown or necrosis. The frequency of severe necrosis has decreased from 24% to 13%. The anatomic result of the vaginal reconstructions appears to have been enhanced by these changes in technique.

Re-treatment of patients with recurrent epithelial ovarian cancer with cisplatin-based chemotherapy.

Nineteen patients with recurrent epithelial ovarian cancer who had responded to initial cisplatin-based combination chemotherapy were re-treated with cisplatin-based therapy. The median disease-free interval, as measured from the last cycle of primary chemotherapy to the diagnosis of relapse, was 26.3 months (range 5-81 months). Eighteen of the 19 patients had measurable disease at the time of relapse. Nine patients had a clinical complete response to the cisplatin-based re-treatment, and nine patients had a partial response (surgically documented in one case). The overall response rate to secondary cisplatin-based chemotherapy was therefore 100% in patients with measurable disease. Toxicity of re-treatment was acceptable. The median progression-free survival, as measured from the diagnosis of relapse to the time of disease progression, was 10.6 months (range 4-24 months). The median survival from diagnosis of relapse was 19.3 months (range 5-39 months). At the time of analysis, three patients were alive without evidence of disease, four were alive with tumor, and 12 were dead of cancer. These data suggest that re-induction with cisplatin-based chemotherapy should be considered for patients who develop recurrent disease after favorable responses to primary cisplatin-based chemotherapy.

Pelvic endometriosis simulating colonic malignant neoplasm.

Three women had endometriosis that involved the rectosigmoid colon; their clinical presentation suggested primary colonic malignant neoplasm. Intestinal obstruction, weight loss, and, in two patients, rectal bleeding with radiologic evidence of a mass lesion that involved the rectosigmoid were present at initial evaluation. All patients eventually underwent colonic resection as definitive therapy. Endometriosis of the pelvic colon may mimic primary intestinal disease, mistakenly suggesting malignant neoplasm. Such symptoms in a young woman should prompt a search for endometriosis, which is a more likely diagnosis. Adequate therapy frequently requires surgical intervention.

Treatment of advanced epithelial ovarian cancer with cisplatin and cyclophosphamide.

Between June 1981 and June 1984, 50 patients with stage III or IV epithelial ovarian cancer underwent initial surgery followed by combination chemotherapy with cisplatin 50 mg/m2 iv and cyclophosphamide 500-1000 mg/m2 iv at 28-day intervals. No patients with borderline or well-differentiated tumors were included. If patients were clinically disease-free after 12 cycles of therapy, a second-look laparotomy was performed. A complete response was noted in 12 patients (24%), 11 of whom were surgically evaluated. A partial response was noted in 4 patients (8%), 3 of whom were surgically evaluated. Thirty-four patients (68%) had no response to therapy. The median progression-free survival (PFS) for the entire group was 19.8 months, with a median survival of 27 months. Patients with less than or equal to 2 cm residual disease had a superior median PFS (25.4 months vs 18 months) and median survival (29.4 months vs 19.5 months) to those patients with greater than 2 cm residual disease. Patients who underwent primary debulking had a longer median survival than patients who underwent "interval" debulking after two to four cycles of chemotherapy (29.2 months vs 17.3 months). Thirteen patients (26%) are alive without evidence of disease, 4 patients are alive with disease, and 33 patients are dead of disease. Toxicity was very moderate. In summary, the activity and toxicity of the combination of cisplatin and cyclophosphamide compare favorably to other cisplatin combination regimens.

Recurrent cervical carcinoma after radical hysterectomy.

The characteristics of recurrent carcinoma following radical hysterectomy and pelvic lymphadenectomy for cervical carcinoma are not well known. Disease recurrence was noted in 27 of 249 patients (11%) with stage IB cervical carcinoma who were treated with a primary surgical approach between January 1962 and December 1984. Fourteen recurrences (52%) occurred within 1 year of surgery, and 24 (89%) within 2 years. Patients with pelvic node metastases or adenocarcinoma had a significantly higher recurrence rate than did patients with negative nodes (33% vs 8%) or with squamous carcinoma (22% vs 8%). Seventeen patients (63%) had disease recurrence in the pelvis or vulva and 12 of these patients had recurrences within 1 year. Eight patients developed asymptomatic pelvic or vulvar recurrences, and all were diagnosed within 1 year. Ten patients (37%) developed recurrences outside the pelvis and 8 of these experienced recurrence after 1 year. Successful treatment after recurrence was independent of clinical or histopathologic parameters except site of recurrence. Eight of 15 patients (53%) who were treated with irradiation for a recurrence in the pelvis or vulva are free of disease 10 to 126 months (median, 48 months) after recurrence. Since irradiation can aid in salvaging patients with recurrent cervical carcinoma confined to the pelvis following radical surgery, clinical vigilance for this site of recurrence is emphasized.