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Biomedical subjects

Robert Dreicer

Publications and source records attributed to Robert Dreicer.

14 recordsLinked to original sources
PubMed2003

Phase II trial of gemcitabine and docetaxel in patients with advanced carcinoma of the urothelium: a trial of the Eastern Cooperative Oncology Group.

BACKGROUND: Gemcitabine and docetaxel are active agents in advanced urothelial carcinoma. A Phase II trial of this combination was performed to determine the activity and toxicity of these agents in a multiinstitutional setting in patients previously treated with one prior chemotherapy regimen. METHODS: Twenty-nine eligible patients with advanced urothelial carcinoma were treated with docetaxel at a dose of 40 mg/m(2) over 1 hour followed by gemcitabine, 800 mg/m(2), over 30 minutes, both intravenously (i.v.) on Days 1 and 8. Cycles were repeated every 21 days until disease progression or a maximum of 6 cycles. RESULTS: Five patients obtained an objective response for an overall response rate of 17% (90% confidence interval, 7-33%). One patient achieved a complete clinical response. The median overall survival of the group was 7.7 months. Toxicity was moderate with granulocytopenia, anorexia, and fatigue being the most commonly noted side effects. CONCLUSIONS: Gemcitabine and docetaxel is an active second-line combination in patients with advanced urothelial carcinoma. Responses in visceral, lymph node, and soft tissues sites were observed. Granulocytopenia without fever, fatigue, and anorexia was common. Thromboembolic symptoms were reported and are of concern. The combination of gemcitabine and docetaxel has the potential to palliate a subset of previously treated patients with an adequate performance status.

Aged↗
PubMed2003

Overview of advanced urothelial cancer trials of the Eastern Cooperative Oncology Group.

Advanced transitional cell carcinoma of the urothelium is an aggressive malignancy characterized by a median survival period of less than 1 year. Although this disease is moderately chemotherapy-sensitive, to the authors' knowledge the impact of therapy reported to date on survival has been minimal. The authors presented an overview of the results from a series of clinical trials conducted over a 25-year period under the auspices of the Eastern Cooperative Oncology Group. They reviewed a series of antineoplastic agents identified by these studies with activity in advanced urothelial cancer and discussed current and future investigational goals and directions.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed2003

Paracolic recurrence of stage I seminoma.

Paracolic recurrence of testicular germ cell tumors is rare and is usually related to incomplete excision of the ipsilateral spermatic cord. We describe a paracolic recurrence outside of the standard radiation field of a low-stage pure seminoma that was managed by chemotherapy and surgical excision, rendering the patient disease free with short-term follow-up.

Adult↗
PubMed2003

A phase II study of 13-cis retinoic acid plus interferon alpha-2a in advanced stage penile carcinoma: an Eastern Cooperative Oncology Group study (E3893).

PURPOSE: Combined biological therapy with 13-cis-retinoic acid (13-cRA) and interferon alpha-2a (IFN alpha-2a) was reported to be highly effective in squamous cell carcinoma of the cervix and skin. Squamous cell carcinoma of the penis is rare in the United States, accounting for less than 1/2% of all male malignancies. Because of the association of infection with human papillomavirus with both carcinomas of the cervix and penis and their shared squamous cell histology, we carried out a phase II study of 13-cRA and IFN alpha-2a in carcinoma of the penis. MATERIALS AND METHODS: Eighteen ambulatory patients with surgically unresectable, recurrent, and/or metastatic squamous cell carcinoma of the penis were treated with IFN alpha-2a, 3MU/day administered subcutaneously and 13-cRA, 1 mg/kg orally daily for at least eight weeks, unless intolerable toxicity occurred. RESULTS: One patient was ineligible; one patient withdrew prior to treatment. Among the 16 eligible, treated patients, there was one complete response. Fourteen patients had progressive disease as their only treatment effect. Two patients were unevaluable for tumor response because they had no follow-up tumor measurements. No unexpected treatment-related toxicities were found on study. The only common form of grade 3 toxicity was hypertriglyceridemia found in eight of the 17 patients (47%). No toxicities above grade 3 were observed. CONCLUSION: In contrast to its benefit in squamous cell carcinomas of the cervix and skin, the combination of 13-cRA and IFN alpha-2a has low efficacy in advanced carcinoma of the penis.

Adult↗
PubMed2003

Neoadjuvant chemotherapy for bladder cancer: current status.

Muscle-invasive bladder cancer is typically an aggressive solid tumour with the propensity for early systemic dissemination. Although curative-intent local therapy with either radical cystectomy or radiotherapy remains the gold standard intervention, the high rate of systemic failure has prompted investigators to evaluate various strategies in an attempt to improve survival, including the early administration of systemic chemotherapy. Recently completed, Phase III studies of neoadjuvant chemotherapy trials demonstrated a modest, but real survival advantage for a small subset of patients. Other strategies include, attempts to both preserve the bladder using combinations of limited surgical resection, systemic chemotherapy and radiotherapy. This review focuses on the potential of neoadjuvantly-administered therapies to impact the management of muscle invasive bladder cancer.

Antineoplastic Agents↗
PubMed2003

Phase I trial of consensus interferon in patients with metastatic renal cell carcinoma: toxicity and immunological effects.

PURPOSE: The purpose of our study was to determine the maximum tolerated dose (MTD), dose-limiting toxicities, and effects on chemokine/cytokine gene expression in peripheral blood mononuclear cells (PBMCs) of consensus IFN (CIFN). EXPERIMENTAL DESIGN: Cohorts of three to six patients with metastatic renal cell carcinoma (RCC) were treated with escalating doses of CIFN (dose level I, 9.0 microg/m(2); dose level II, 15.0 microg/m(2); dose level III, 21.0 microg/m(2)) given s.c. three times weekly in 4-week cycles until progression. The cohort treated at the maximum tolerated dose was expanded to further define toxicity. An additional three patients were treated with i.v. CIFN (15.0 microg/m(2)) to evaluate route-related differences in gene expression. Cytokine and chemokine gene expression in PBMCs was assessed by reverse transcription-PCR. RESULTS: A total of 25 patients (18 men and 7 women) were enrolled between January 28, 1999, and November 1, 2000, at dose levels I (n = 4), II (n = 14), and III (n = 7). Dose-limiting toxicity occurred at dose level III (21 microg/m(2)) and included grade-3 or -4 respiratory distress/failure (n = 3) and hypocalcemia (n = 1) occurring within the first cycle of treatment. Other severe toxicities included grade-3 neutropenia, thrombocytopenia, fatigue, and nausea/vomiting. Studies of cytokine and chemokine gene expression in PBMCs from eight patients revealed induction of IFN-gamma, IP-10, and Mig. I.V. administration was associated with a faster induction, but of shorter duration. There were no responses; however, 24 patients had stable disease of variable duration (4-32 weeks) and received a median of three cycles of treatment (range, 1-8 cycles). Overall median survival was 13.5 months, and was 12.7 months in the previously treated patients. CONCLUSION: CIFN was safely administered s.c. three times weekly at doses up to 15.0 microg/m(2). Although there were no responses, the median survival was longer than expected in a previously treated patient population with metastatic RCC.

Adult↗
PubMed2002

Phase II study of paclitaxel plus carboplatin in patients with advanced carcinoma of the urothelium and renal dysfunction (E2896): a trial of the Eastern Cooperative Oncology Group.

BACKGROUND: Chemotherapy options for the patients with advanced urothelial carcinoma and renal dysfunction are limited. The authors performed a Phase II trial of paclitaxel plus carboplatin in patients with advanced carcinoma of the urothelium and renal dysfunction. METHODS: Forty-two patients were accrued; 37 eligible patients were treated. Patients received paclitaxel 225 mg/m(2) over three hours followed by carboplatin targeted area under the concentration-time curve = 6 mg/mL. minute every three weeks for up to six cycles. RESULTS: The median number of cycles received was four (range, one to six). The objective response rate was 24.3% (95% confidence interval, 11.9-41.7%). The median progression free survival was 3 months and the median overall survival was 7.1 months. The number of poor prognostic risk factors (Eastern Cooperative Oncology Group performance status > 1 or lung, liver, or bone metastases) significantly predicted for survival. The most common > or = 1 Grade 3 toxicities included granulocytopenia (60%) and neurotoxicity (35%). CONCLUSIONS: Paclitaxel/carboplatin is a chemotherapy option for patients with advanced urothelial carcinoma and renal dysfunction. Future trials in chemotherapy development for this patient population are warranted.

Adult↗
PubMed2002

Preoperative combined nested reverse transcriptase polymerase chain reaction for prostate-specific antigen and prostate-specific membrane antigen does not correlate with pathologic stage or biochemical failure in patients with localized prostate cancer undergoing radical prostatectomy.

PURPOSE: We report a prospective study examining the ability of preoperative nested reverse transcriptase polymerase chain reaction (RT-PCR) for prostate-specific antigen (PSA) and prostate-specific membrane antigen (PSM) to predict pathologic stage and biochemical recurrence in patients with clinically localized prostate cancer treated with radical prostatectomy. PATIENTS AND METHODS: One hundred forty-one patients were entered onto the study. Preoperative evaluation included clinical T stage, serum PSA, biopsy Gleason score, and serum RT-PCR for PSA/PSM. Univariate and multivariate logistic regression models, Kaplan-Meier estimates, and Cox proportional hazards modeling were used to identify predictors of pathologic stage and biochemical failure. RESULTS: Seventy-three patients (51.8%) were RT-PCR positive for PSA, PSM, or both. In the multivariate logistic regression model, only initial PSA was an independent predictor of pathologic stage as defined by organ-confined disease (odds ratio [OR], 1.06; 95% confidence interval [CI], 1.00 to 1.13; P =.026) or organ-/specimen-confined disease (OR, 1.09; 95% CI, 1.02 to 1.16; P =.009). Overall Kaplan-Meier biochemical relapse-free survival (bRFS) was 85% at 59 months. Multivariate analysis of predictors for bRFS with the Cox proportional hazards model indicated that only initial PSA (OR, 1.05; 95% CI, 1.02 to 1.09; P =.004) and biopsy Gleason score (OR, 3.57; 95% CI, 1.37 to 9.58; P =.009) were independent predictors of biochemical failure. RT-PCR status did not predict pathologic stage or biochemical failure. Repeat analysis excluding 27 patients who received preoperative androgen-deprivation therapy did not change the results. CONCLUSION: Combined nested RT-PCR for PSA and PSM is not an independent predictor of pathologic stage or biochemical failure in patients with localized prostate cancer undergoing radical prostatectomy. This assay has no clinical utility in this patient population.

Antigens, Surface↗
PubMed2002

Controversies in the systemic management of patients with evidence of biochemical failure following radical prostatectomy.

The management of patients with evidence of a detectable prostate-specific antigen (PSA) following prostatectomy is an increasingly common and difficult issue for patients and clinicians alike. In the setting in which biochemical failure is believed representative of early systemic failure, therapeutic options primarily involve the use of hormonal therapy. Extrapolating results of early vs. delayed hormonal therapy from studies of patients with more advanced prostate cancer is problematic. Antiandrogen monotherapy and intermittent androgen deprivation are increasingly popular approaches, although their ultimate utility remains unproven. This patient subset is an optimal one in which to conduct clinical trials to both define the role of hormonal therapy and to investigate novel, non-hormonal approaches. The most appropriate therapeutic intervention for patients with evidence of biochemical failure following radical prostatectomy remains undefined.

Androgen Antagonists↗
PubMed2002

Piritrexim in advanced, refractory carcinoma of the urothelium (E3896): a phase II trial of the Eastern Cooperative Oncology Group.

UNLABELLED: This was a single-agent phase II clinical trial of the antifol piritrexim in patients with advanced transitional cell carcinoma of the bladder. METHODS: Patients with previously-treated, advanced urothelial carcinoma were treated with oral piritrexim at a dose of 25 mg three times daily for 5 consecutive days each week for 3 consecutive weeks followed by a 1-week rest period. Courses were repeated every 28 days. RESULTS: Thirty-five patients were enrolled in the study, with 28 patients evaluable for survival and toxicity and 27 evaluable for response. TOXICITY: Myelosuppression was the major dose-limiting toxicity, with WHO grade 3/4 thrombocytopenia in 4 patients, granulocytopenia in 1 patient, and anemia in 3 patients. Grade 3 nonhematologic toxicity consisted of neuropathy in 5 patients, hepatotoxicity in 2, nausea in 2, and 1 each with pulmonary toxicity and rash. EFFICACY: Of the 27 patients evaluable for response, 2 (7%) achieved an objective response, lasting 112 and 142 days, respectively. CONCLUSION: Piritrexim has minimal activity in patients with previously treated transitional cell carcinoma of the bladder, regardless of prior exposure to methotrexate, and further evaluation of this compound in this clinical setting is not warranted.

Aged↗
PubMed2002

Management of stage I nonseminomatous germ-cell tumors.

Following orchiectomy in patients with stage 1 nonseminomatous germ-cell tumors (NSGCT), there are three treatment options. Retroperitoneal lymph-node dissection (RPLND) is currently the treatment of choice in the United States and can be both diagnostic and therapeutic but is associated with surgical morbidities. Surveillance is the least invasive but carries the highest potential for relapse and can be timely and costly for both patient and physician. Primary chemotherapy avoids the morbidity of surgery while achieving similar survival rates, albeit with potentially significant side effects. The advantages and disadvantages of each treatment modality are discussed.

Germinoma↗
PubMed2002

Brain metastases from bladder carcinoma: presentation, treatment and survival.

PURPOSE: We report the presentation of brain metastases from bladder carcinoma. We investigated the role of whole brain radiation therapy for treating this disease. MATERIALS AND METHODS: Between January 1982 and November 1999, 16 patients with brain metastases from bladder carcinoma were treated at our institution. We reviewed patient and tumor characteristics at the time of the primary diagnosis and the brain metastasis diagnosis. We analyzed treatment results in regard to survival and local metastasis control. RESULTS: Brain metastases from bladder carcinoma were commonly accompanied by uncontrolled systemic metastases. Multiple brain lesions developed in 14 of the 16 patients. Of the 16 patients 14 received radiation therapy with or without surgery, 1 was treated surgically and 1 did not receive any treatment. The 11 patients treated with whole brain radiation therapy had a median survival of only 2 months (range 0.5 to 11). A patient who received stereotactic radiosurgery survived 12 months after the brain metastasis diagnosis and 2 treated with radiation therapy after surgery survived 12.75 and 2.75 months, respectively (median 7.75). The patient treated with surgery alone survived 1.25 months after the brain metastasis diagnosis and 1 who received no treatment survived 1.75 months. Patients with multiple brain metastases had shorter survival than those with a single metastasis. CONCLUSIONS: Overall survival after brain metastasis development in patients with bladder carcinoma was poor. Although the number of patients in this study was small, results indicate that radiation therapy alone is inadequate treatment. Therefore, when possible, we advocate more effective treatment by combining radiation therapy with other treatment modalities, as recommended in ongoing clinical trials.

Adult↗