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ABSTRACT: To examine histologic findings and clinical outcomes of patients who underwent neck dissection for residual neck masses.
From 1987 to 2008, 968 postchemotherapy retroperitoneal lymph node dissections (RPLND) were performed at our institution. We identified 41 of these patients who underwent a postchemotherapy residual neck mass resection.
Thirty-nine patients presented with primary testis, one with retroperitoneal, and one with mediastinal GCT. Teratoma was present in 54% of patients at diagnosis. During the neck dissection, 23 (56.1%) patients had teratoma, 14 (34.2%) had fibrosis, three (7.3%) had viable GCT, and one had benign lymph nodes. There was histologic discordance between the neck and the RPLND in 22.5% of patients and between the neck and other extraretroperitoneal resection sites in 26.5% of patients. At a median follow-up of 49.5 months from diagnosis, 16 patients had recurrence, and seven had died of testis cancer. No patient had recurrence in the neck. Five of seven patients with residual viable cancer at extraretroperitoneal resection sites died of disease compared with two of 23 with teratoma and none with fibrosis (P = .0005).
Resection of residual postchemotherapy neck masses is indicated because of the high incidence of viable tumor or teratoma in the residual mass and the inability to accurately predict the histology of the neck masses. Resection of residual neck masses leads to excellent local control and can contribute to long-term disease control and survival.
Urology 03/2011; 77(3):655-9. · 2.43 Impact Factor
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ABSTRACT: This phase II trial (Cancer and Leukemia Group B 90102) sought to determine the efficacy of cisplatin, standard infusion of gemcitabine and gefitinib in patients with advanced urothelial carcinoma.
Eligible patients had previously untreated measurable disease, Eastern Cooperative Oncology Group (ECOG) performance status of zero to two and creatinine clearance >50 ml/min. Treatment consisted of cisplatin 70 mg/m(2) day 1 and gemcitabine 1000 mg/m(2) on days 1 and 8 given every 3 weeks concurrent with gefitinib 500 mg/day orally for six cycles. Maintenance gefitinib 500 mg/day was continued for responding or stable disease.
Fifty-four of 58 patients were assessable. Twelve patients (22%) had node-only disease, and 25 (46%) had an ECOG performance status of zero. There were 23 objective responses for an overall response rate of 42.6% [95% confidence interval (CI) 29.2% to 56.8%]. The median survival time was 15.1 months (95% CI 11.1-21.7 months) and the median time to progression was 7.4 months (95% CI 5.6-9.2 months).
The combination of cisplatin, gemcitabine and gefitinib is well tolerated and active in advanced transitional cell carcinoma. The addition of gefitinib does not appear to improve response rate or survival in comparison to historical controls of cisplatin and gemcitabine alone.
Annals of Oncology 01/2009; 20(6):1074-9. · 6.43 Impact Factor
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W K Kelly,
T Curley,
S Slovin,
G Heller,
J McCaffrey, D Bajorin,
A Ciolino,
K Regan,
M Schwartz,
P Kantoff,
D George,
W Oh,
M Smith,
D Kaufman,
E J Small,
L Schwartz,
S Larson,
W Tong,
H Scher
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ABSTRACT: To determine the safety and activity of weekly paclitaxel in combination with estramustine and carboplatin (TEC) in patients with advanced prostate cancer.
In a dose-escalation study, patients with advanced prostate cancer were administered paclitaxel (weekly 1-hour infusions of 60 to 100 mg/m(2)), oral estramustine (10 mg/kg), and carboplatin (area under the curve, 6 mg/mL-min every 4 weeks). Paclitaxel levels were determined 0, 30, 60, 90, and 120 minutes and 18 hours after infusion, and a concentration-time curve was estimated. Once a safe dose was established, a multi-institutional phase II trial was conducted in patients with progressive androgen-independent disease.
Fifty-six patients with progressive androgen-independent disease were treated for a median of four cycles. The dose of paclitaxel was escalated from 60 to 100 mg/m(2) without the occurrence of DLT. Posttherapy decreases in serum prostate-specific antigen levels of 50%, 80%, and 90% were seen in 67%, 48%, and 39% (95% confidence interval, 55% to 79%, 35% to 61%, 26% to 52%) of the patients, respectively. Of the 33 patients with measurable disease, two (6%) had a complete response and 13 (39%) had a partial response. The overall median time to progression was 21 weeks, and the median survival time for all patients was 19.9 months. Major grade 3 or 4 adverse effects were thromboembolic disease (in 25% of patients), hyperglycemia (in 38%), and hypophosphatemia (in 42%). Significant leukopenia, thrombocytopenia, and peripheral neuropathy were not observed.
TEC has significant antitumor activity and is well tolerated in patients with progressive androgen-independent prostate cancer.
Journal of Clinical Oncology 02/2001; 19(1):44-53. · 18.37 Impact Factor
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ABSTRACT: To evaluate the dose, toxicity, and efficacy of paclitaxel in combination with ifosfamide and cisplatin as salvage therapy for patients with relapsed testicular germ cell tumors (GCTs).
Thirty patients with previously treated GCTs were treated with paclitaxel and ifosfamide plus cisplatin (TIP) as second-line therapy. All had favorable prognostic features for response (testis primary tumor site and prior complete response to first-line chemotherapy program). Four cycles of paclitaxel, ifosfamide 5 g/m(2), and cisplatin 100 mg/m(2) were given 21 days apart with granulocyte colony-stimulating factor support, followed by resection of radiographic residua. The dose of paclitaxel was increased among cohorts with dose levels of 175, 215, and 250 mg/m(2); the largest dose was selected for the phase II part of the trial.
Twenty-three (77%) of 30 patients achieved a complete response to chemotherapy alone, and one patient achieved a durable partial response with normal tumor markers. Therefore, 24 (80%) achieved a favorable response. Eleven patients with normalized markers after chemotherapy underwent resection of residual tissue, with only necrosis found in 10 and mature teratoma in one. Two patients relapsed, and 22 (73%) of the favorable responses remain durable at a median follow-up duration of 33 months. Myelosuppression was the major toxicity, and two patients had grade 3 neurotoxicity.
Four cycles of TIP was associated with a high proportion of patients who achieved a complete response, a lack of relapse, and relative tolerability as an ifosfamide-containing salvage regimen for testicular GCTs. The high durable complete response proportion emphasizes the importance of patient selection according to prognostic factors for a favorable outcome to conventional-dose salvage therapy.
Journal of Clinical Oncology 07/2000; 18(12):2413-8. · 18.37 Impact Factor
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ABSTRACT: To help fill the gap in knowledge about the risk of leukemia from repetitive high-dose use of alkylating agents and topoisomerase-II inhibitors in young patients with solid tumors.
Poor-risk solid tumors were treated with four courses of cyclophosphamide (4,200 mg/m2)/ doxorubicin (75 mg/m2), and three courses of ifosfamide (9,000 mg/m2)/etoposide (500 mg/m2). The cumulative incidence of treatment-related myelodysplasia/ leukemia (t-AML) was calculated using the method of competing risks. The expected number of leukemic events was calculated by applying national incidence rates to person-years classified by age and sex.
Among 86 patients (median age, 17 years) monitored for 6 to 88 months (median, 24), five cases of t-AML were detected at 10 to 37 months (median, 17). The expected number of leukemic events in this cohort was .001. Clinical and cytogenetic findings implicated prior alkylator therapy in three cases and prior treatment with topoisomerase-II inhibitors in two. At 40 months, the cumulative incidence of t-AML was 8% (SE 7%).
Repetitive high-dose use of alkylating agents given with topoisomerase-II inhibitors is strongly leukemogenic, even with modest cumulative doses of each drug. This finding is notable for the following reasons: (1) it undermines predictions that limited use of high-dose chemotherapy might be minimally leukemogenic, and (2) it contrasts strikingly with the previously reported low risk of t-AML following treatment of pediatric solid tumors with chemotherapy lacking the alkylator dose-intensity and prominence of etoposide that are hallmarks of current regimens.
Journal of Clinical Oncology 10/1998; 16(9):3016-20. · 18.37 Impact Factor
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ABSTRACT: Serum tumor marker regression (alpha-fetoprotein [AFP] and human chorionic gonadotrophin [hCG]) was studied in patients treated with ifosfamide-based chemotherapy for cisplatin-resistant germ cell tumors (GCT) to investigate the role of marker regression as a predictor of treatment outcome.
Fifty-four patients treated with cisplatin and ifosfamide-containing therapy were the subject of this retrospective analysis. The serum tumor marker half-life (T1/2) for the first two cycles of therapy was calculated for each patient using all marker values Day 7 through the end of the second treatment cycle. A calculated T1/2 for hCG of less than or equal to 3 days or a calculated T1/2 for AFP of less than or equal to 7 days was defined as appropriate marker regression; any T1/2 greater than these values was considered prolonged. A variable designated "marker decline" was defined to indicate whether the serum tumor marker half-life of AFP and/or hCG was satisfactory or unsatisfactory for each individual patient. Both univariate and multivariate analyses were conducted to investigate "marker decline" as a predictor for response, event-free survival (time to death or relapse), and overall survival.
Satisfactory marker decline predicted an improved event-free survival and overall survival. The median event-free survival for patients with an unsatisfactory marker decline was 5.8 months versus 20.7 months for patients with a satisfactory marker decline. Survival for patients with an unsatisfactory marker decline was 6.3 months versus 20.7 months for those patients with a satisfactory marker decline. Further evaluation demonstrated that hCG decline was a stronger predictor for improved survival than AFP decline. A multivariate analysis performed on selected clinical variables using a Cox regression model demonstrated that marker decline, pretreatment hCG, and primary site were independent predictors for event-free and overall survival.
The rate of serum AFP and/or hCG decline during the first two cycles of therapy was predictive for event-free and overall survival in GCT patients treated with ifosfamide-based salvage therapy. Those patients with an appropriate serum tumor marker decline had a longer event-free and overall survival. When evaluated separately, the rate of hCG decline was more predictive of treatment outcome than decline of AFP. The rate of serum tumor marker regression during the first two cycles of therapy is a clinically useful tool in assessing treatment outcome at an early point in therapy and may thereby identify patients who could benefit from a change to more intensive therapy.
Cancer 06/1994; 73(10):2520-6. · 4.77 Impact Factor
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ABSTRACT: To evaluate the activity and toxicity of the drug combination cisplatin, fluorouracil by continuous infusion, and high-dose oral leucovorin calcium (PFL) as induction chemotherapy in patients with advanced and untreated squamous cell head and neck (SCHN) cancer.
Nonrandomized, prospective trial.
Referral center (comprehensive cancer center).
Twenty-two patients with stage III (n = 7) and IV (n = 15) M0 SCHN cancer of the larynx (n = 13), hypopharynx (n = 7), and oropharynx (n = 2) whose standard treatment would have required total laryngectomy.
Three cycles of PFL were administered prior to local-regional therapy (concomitant cisplatin and radiation and/or neck dissection, with total laryngectomy reserved for nonresponse or relapse). Chemotherapy included cisplatin (100 mg/m2) on day 1 by short intravenous infusion; fluorouracil (800 mg/m2) on days 1 through 5 by continuous infusion; and leucovorin (100 mg) every 4 hours by mouth for 30 doses. The PFL combination was administered every 21 days.
Clinical response to chemotherapy and observed toxic effects during chemotherapy.
Five patients were inevaluable for response, with three early deaths (infection in two and sudden death in one), one cerebrovascular accident, and one patient declining further chemotherapy. Of the remaining 17 patients, 10 had a major response to chemotherapy, but in only five patients (29%) was this complete (95% confidence interval, 8% to 51%). Other significant toxic effects included grade 3 to 4 mucositis in eight patients and grade 3 to 4 neutropenia in 10.
While PFL is active in patients with SCHN cancer, we were unable to reproduce the high complete response rates reported by other centers. Its use can be associated with significant toxic effects. We do not recommend the use of PFL for the treatment of patients with SCHN cancer outside the context of a clinical trial until there is further critical assessment of its activity and toxicity.
Archives of Otolaryngology - Head and Neck Surgery 02/1994; 120(1):89-95. · 1.63 Impact Factor
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ABSTRACT: Fifteen patients with recurrent squamous cell head and neck cancer were treated with deoxyspergualin. There were no objective responses in 14 evaluable patients. The most common toxicity was reversible hypotension, which prompted dose reduction in nine patients. Deoxyspergualin is not recommended for the treatment of squamous cell head and neck cancer.
Investigational New Drugs 03/1993; 11(1):53-6. · 3.36 Impact Factor
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ABSTRACT: The role of surgery in patients with advanced germ-cell tumors after chemotherapy has evolved substantially in the era of combined modality therapy. In evaluating patients for surgery after chemotherapy, the clinician must consider carefully the histologic type (seminoma versus nonseminomatous germ-cell tumors) of the primary tumor as well as the extent of the residual disease. Criteria designed to select patients with non-seminomatous tumors in whom the surgical histologic findings are negative are associated with substantial error. A normal radiographic evaluation in patients with nonseminomatous germ-cell tumors is not entirely predictive of negative pathology findings, and the treating physician must consider the risk of residual tumor despite a radiographic complete remission. In contrast, patients with seminoma have less potential for residual tumor, and the size of the residual disease permits more accurate selection of patients who still have malignancy. Continued research is needed to improve the sensitivity and specificity of patient selection for surgery after chemotherapy in order to limit the toxicity of curative therapy.
Urologic Clinics of North America 03/1993; 20(1):133-43. · 1.82 Impact Factor
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ABSTRACT: The allocation of patients with advanced germ cell tumors (GCT) to different treatment programs based on clinical characteristics is standard in the design of clinical trials today. Studies have shown that substantial differences exist between entry criteria and that these differences could influence the outcome of clinical trials. The factors contributing to these differences are not clear due to patient selection biases. Two hundred five unselected and consecutive patients allocated to and treated in good-risk and poor-risk treatment programs at Memorial Sloan-Kettering Cancer Center (MSKCC) were reassigned risk status by the Indiana University (IU) Classification. The results were compared with those of the Southeastern Cancer Study Group (SECSG). The results using both criteria indicated substantial agreement in total end results and the identification of good-risk patients. The results in poor-risk patients differed substantially, with 39 patients (19%) classified as poor-risk by MSKCC criteria and 66 (32%) by Indiana criteria. The major discrepancy occurred in IU Stage 7, in which 26 of 32 patients (81%) achieved a complete response. The major factor contributing to this difference in risk assignment was the use of serum tumor markers. Serum tumor markers must be incorporated into risk assignment criteria for GCT clinical trials to minimize the number of good-risk GCT patients in poor-risk trials.
Cancer 04/1991; 67(5):1299-304. · 4.77 Impact Factor
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ABSTRACT: Adoptive immunotherapy with recombinant interleukin-2 (rhIL-2) has been reported to induce tumour regression in some patients with refractory cancer. However, the cardiovascular toxicity of bolus therapy requires invasive monitoring of patients in the intensive care unit (ICU). In an effort to examine the haemodynamic alterations caused by a constant infusion of IL-2, as opposed to bolus therapy, we studied the haemodynamic variables of 10 patients, with no evidence of heart disease, receiving 3 x 10(6) IU/m2 per day of rhIL-2 as a continuous infusion for 5 days. Measured and derived haemodynamic variables were obtained immediately prior to, at 2, 24, and 48 h during, and upon termination of the infusion. There was no evidence of clinical haemodynamic instability in these patients. Except for development of fever and tachycardia, there were no clinically significant differences in any measured or derived haemodynamic parameter. Moreover, continuous electrocadiographic monitoring of these patients during the infusion did not reveal any abnormalities. Invasive haemodynamic monitoring in an ICU is not necessary in carefully selected patients receiving constant infusion rhIL-2, at the described dose and schedule.
European Journal of Cancer 02/1991; 27(12):1613-6. · 5.54 Impact Factor
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ABSTRACT: Previous pharmacological and clinical data have suggested that it is possible to increase significantly the dose of "active" cisplatin delivered systemically by the simultaneous administration of intravenous sodium thiosulfate. In order to define more critically the toxicity and potential efficacy of this therapeutic approach, 36 patients with a variety of solid tumors and limited pretreatment were entered into a phase-1 trial of high-dose intravenous cisplatin plus sodium thiosulfate. The maximally tolerated dose of cisplatin was found to be 200 mg/m2, excessive renal toxicity being observed at a dose of 225 mg/m2 (6/14 courses associated with serum creatinine rise to greater than 2.0 mg-%). Following several courses of high-dose cisplatin, peripheral neuropathy becomes the limiting toxicity (9/15 patients receiving at least three courses of cisplatin at greater than or equal to 150 mg/m2 experienced at least grade-1 neuropathy). Significant ototoxicity developed after only one or two treatment courses, but with continued treatment hearing loss appeared to stabilize in the moderately severe range in most patients. Major responses (PR/CR) were observed in 7/27 evaluable patients. We conclude that cisplatin can be administered at a dose at 200 mg/m2 as a 2-h infusion (with simultaneous sodium thiosulfate) with significant but acceptable toxicities and without evidence of loss of anti-neoplastic activity (secondary to the presence of thiosulfate). However, owing to the development of neurotoxicity most patients will be unable to receive more than three courses of this high-dose treatment regimen.
Journal of Cancer Research and Clinical Oncology 02/1991; 117(2):151-5. · 2.56 Impact Factor
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ABSTRACT: Twenty-three patients with advanced renal cell cancer were treated with Didemnin B. One partial response was achieved (5%) in 21 evaluable patients. An allergic reaction was noted in four patients including one patient with anaphylaxis. Didemnin B is not recommended in the treatment of renal cell carcinoma.
Investigational New Drugs 12/1990; 8(4):391-2. · 3.36 Impact Factor
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ABSTRACT: One hundred eighty-five patients who underwent surgery within 6 months of completing chemotherapy were identified from 360 patients with nonseminomatous germ cell tumors (NSGCT) treated with Memorial Hospital front-line cisplatin- or carboplatin-based combination chemotherapy protocols between 1979 and 1988. Clinical, pathologic, and radiologic features were correlated with the pathologic findings at surgery. The size of a residual retroperitoneal mass, the degree of shrinkage that occurred with chemotherapy, and the presence of teratomatous elements in pretreatment pathology specimens were each correlated with the pathologic findings of retroperitoneal resections after chemotherapy. Multivariable logistic regression analysis of those undergoing retroperitoneal resections identified the size and shrinkage of the residual mass and the prechemotherapy lactate dehydrogenase (LDH) and alphafetoprotein (AFP) levels as the best predictors of finding only necrotic debris. No factors could be found, however, that could selectively exclude patients who had residual viable malignancy or teratoma in the retroperitoneum. Of 39 patients with residual retroperitoneal masses measuring less than or equal to 1.5 cm in maximal diameter, three had residual malignancy and five had teratoma resected. No factors were identified for residual lung or mediastinal masses that could be used to select a group of patients who could safely avoid surgery. If serum markers have normalized after chemotherapy for NSGCT, resection of all residual abnormalities on imaging studies of the retroperitoneum, lungs, and mediastinum is recommended. In addition, retroperitoneal lymph node dissection (RPLND) is recommended for all patients with initial bulky metastases (greater than or equal to 3 cm in diameter) in the retroperitoneum, irrespective of the findings of postchemotherapy computed tomography (CT).
Journal of Clinical Oncology 11/1990; 8(10):1683-94. · 18.37 Impact Factor
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ABSTRACT: A prospective study of four cycles of carboplatin (CBDCA) + etoposide + bleomycin (EBC) was conducted in 32 previously poor-risk nonseminomatous germ cell tumor (GCT) patients and the results compared with past studies. Patients with extragonadal (nine patients) and testicular nonseminomatous GCT with a probability of complete response (CR) less than 0.5 as calculated by a mathematical model using marker values and number of metastatic sites (23 patients) were included. Nineteen patients (59%) achieved a CR and 14 complete responders (43%) remain free of disease. The overall and durable CR proportions were similar to those observed in prior poor-risk studies at Memorial Sloan-Kettering Cancer Center. Myelosuppression was the major toxicity. Based on the low CR proportion, EBC is no better than other standard programs for poor-risk GCT. However, its ease of administration as an outpatient, mild renal and gastrointestinal toxicity, and efficacy comparable to cisplatin-based chemotherapy used in prior poor-risk trials at Memorial Sloan-Kettering Cancer Center warrant a Phase III trial comparing CBDCA-based and cisplatin-based chemotherapy for good-risk GCT patients.
Cancer 07/1990; 65(11):2465-70. · 4.77 Impact Factor
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ABSTRACT: Epidural cord compression from germ cell tumor metastases is not common. Treatment usually requires high dose corticosteroids with radiation therapy and/or surgical decompression. Three patients with epidural germ cell tumor metastases were treated with cisplatin-based chemotherapy and all three had complete neurologic recovery. Systemic chemotherapy should be considered as initial therapy with corticosteroids for epidural cord compression from metastatic germ cell tumor.
Journal of Neuro-Oncology 07/1990; 8(3):275-80. · 3.21 Impact Factor
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ABSTRACT: We report the results of a phase II evaluation of carboplatin (CBDCA) in 45 patients with advanced malignant melanoma. Of the 43 evaluable patients, 6 had been treated previously with chemotherapy; 11 had been treated with immunotherapy. The initial dose was 400 mg/m2 i.v. every 4 weeks; the dose was modified as required to achieve moderate myelosuppression. There was one complete response (duration 16 months) and six partial responses, for a major objective response rate of 16%. Toxicity consisted primarily of acute nausea and vomiting, and thrombocytopenia. The activity of CBDCA in this disease is similar to that of cisplatin and dacarbazine.
Investigational New Drugs 06/1990; 8(2):187-90. · 3.36 Impact Factor
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ABSTRACT: A Phase I trial of three carboplatin-based combination chemotherapy regimens was conducted. These included: carboplatin plus vindesine; carboplatin, vindesine, plus bleomycin; and, carboplatin plus vinblastine. Carboplatin was administered every 28 days as an intravenous bolus. The initial dose was 150 mg/m2 and doses were escalated by 50 mg/m2 in each successive group of patients. Vindesine was given at a dose of 3 mg/m2 weekly for 5 doses, then every other week thereafter. Bleomycin, 10 units/m2 IV bolus, was followed by 10 units/m2/day infusion for 4 days (3-7 and 31-35). Vinblastine was given at 5 mg/m2 every other week. Doses of vindesine, vinblastine, and bleomycin were not escalated. The maximum tolerated dose (MTD) of the carboplatin, vindesine +/- bleomycin regimens was reached at a carboplatin dose of 250 mg/m2 and the MTD was influenced by the weekly vindesine in the initial 4 weeks of therapy. The MTD of the carboplatin and vinblastine regimen was reached at a carboplatin dose of 500 mg/m2. Dose-limiting toxicity of all three regimens was leukopenia. Although nonhematological toxicity of the carboplatin and vinblastine regimen included peripheral neuropathy and emesis, therapy was easily administered in an outpatient setting. The recommended Phase II dose of carboplatin is 450 mg/m2 in combination with vinblastine at this dose and schedule for previously untreated patients. Twelve patients demonstrated major responses with the various regimens including 5 of 24 patients with adenocarcinoma of the upper gastrointestinal tract.
Cancer Investigation 02/1990; 8(2):135-41. · 1.85 Impact Factor
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Seminars in Oncology 09/1988; 15(4):339-44. · 3.50 Impact Factor
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ABSTRACT: Standard chemotherapy for disseminated germ cell tumors (GCT) cures most patients but causes considerable acute toxicity, including treatment-related death due to septicemia during neutropenia and pulmonary fibrosis. In addition, chronic and delayed toxicities, particularly Raynaud's phenomenon, have been reported in 6% to 37% of treated patients. In an attempt to minimize the acute and chronic effects of treatment which are related primarily to vinblastine and bleomycin, a randomized trial comparing the efficacy and toxicity of vinblastine + bleomycin + cisplatin + cyclophosphamide + dactinomycin (VAB-6) and etoposide + cisplatin (EP) was conducted on 164 eligible patients with good-prognosis GCT. Seventy-nine of 82 (96%) patients receiving VAB-6 and 76/82 (93%) receiving EP achieved a complete remission (CR) with or without adjunctive surgery. Similar proportions of patients in both arms were found at surgery to have necrosis/fibrosis or mature teratoma. With a median follow-up of 24.4 months in the VAB-6 arm and 25.9 months in the EP arm, the total, relapse-free, and event-free survival distributions were similar in the two arms. Patients receiving EP experienced less emesis (P = .05), higher nadir WBC (P = .06) and platelet counts (P = .01), less magnesium wasting (P = .0001), less mucositis (P = .09), and no pulmonary toxicity. No treatment-related mortality was observed. EP is an efficacious and less toxic regimen and is recommended for good-prognosis patients with disseminated GCT.
Journal of Clinical Oncology 09/1988; 6(8):1231-8. · 18.37 Impact Factor
