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P Sogani

Publications and source records attributed to P Sogani.

At least 19 recordsLinked to original sources
PubMed1997

The indications, rationale, and results of neoadjuvant androgen deprivation in the treatment of prostatic cancer: Memorial Sloan-Kettering Cancer Center results.

OBJECTIVES: The use of neoadjuvant chemotherapy prior to definitive surgery has been firmly established in other areas of oncology, most notably in the treatment to testis and Wilm's tumors. The use of neoadjuvant androgen deprivation therapy (ADT) in conjunction with radical prostatectomy remains a source of controversy. We have conducted phase II and phase III studies to assess the effects of 3 months of preoperative ADT (goserelin and flutamide) on the pathologic staging and postsurgery prostate-specific antigen (PSA) relapse rate. We also reviewed the data confirming the understaging of clinically localized prostatic cancer and the experimental data providing the conceptual support for ADT. METHODS: We report the results of 141 patients, Stage T0-T0, in a Phase II study with concurrent, nonrandomized controls (N = 72) versus a treatment arm (N = 69) of men receiving 3 months of ADT with 3.6 mg goserelin for 28 days and 750 mg flutamide daily. We also report the interim results in 114 men participating in a prospective, randomized study of ADT versus surgery alone. RESULTS: The 69 patients who received 3 months of goserelin and flutamide followed by radical prostatectomy had a pathologic organ-confined cancer rate of 74%, versus 48% in the control group who received no ADT prior to surgery. The margin-positive rate was 10% in the ADT group versus 33% in the control group. In an interim analysis of 114 patients (59 ADT, 55 control), the organ-confined and margin-positive rates were 73% and 17% in the ADT group versus 56% and 36% in the control arm, respectively. The PSA disease-free rate at a mean follow-up of 28.6 months (range 6.2 to 49.5 months) was 89% in the ADT-treated patients (N = 98) and 84% in the control patients (N = 96). There was no statistical difference demonstrated between the arms with respect to biochemical failure. CONCLUSIONS: While the pathologic staging of tumors following ADT treatment was improved compared with surgical controls, to date the PSA disease-free survival rates are similar. Patients with residual extracapsular (P3) disease after ADT manifest an increased PSA failure rate compared with those with P3 tumors treated by surgery alone. This suggests that ADT may identify a subset of patients with aggressive tumors that may be candidates for additional therapeutic interventions even before PSA failure occurs.

Aged↗
PubMed1994

Experience with neoadjuvant diethylstilboestrol and radical prostatectomy in patients with locally advanced prostate cancer.

OBJECTIVE: To report our experience with neoadjuvant endocrine therapy and radical retropubic prostatectomy (RRP) in patients with locally advanced prostate cancer. PATIENTS AND METHODS: Fifty-five patients with prostatic adenocarcinoma (18 clinical stage B2/3, 27 clinical stage C, and 10 clinical stage D0) were treated with diethylstilboestrol (DES) 3 mg/d (median time 12 weeks, range 5-36) followed by pelvic lymph node dissection and planned RRP. Clinical response was monitored bi-weekly with serum prostate-specific antigen (PSA), serum acid phosphatase and digital rectal examination. RESULTS: The median pre-treatment serum PSA was 20.4 ng/ml (range 1.2-620). The median post-treatment, pre-operative serum PSA was 0.4 ng/ml. Twenty-seven (49%), 41 (75%) and 54 (98%) patients had serum PSA levels that were undetectable, < 1.0 ng/ml and < 4.0 ng/ml respectively. In 15 patients, transrectal ultrasound measurement of prostatic volume changes was performed, and all demonstrated prostate volume reduction (median reduction 35%, range 18-45). All 55 patients underwent pelvic lymphadenectomy, with 47 (85%) undergoing RRP. Of the eight patients not undergoing RRP, three had negative lymph nodes but prostate resection was not deemed feasible and five had nodal metastases as determined by frozen section analysis. Final pathological stage revealed the following distribution: organ confined tumours, 18 (33%); capsular perforation with negative surgical margins, seminal vesicles and lymph nodes, seven (13%); seminal vesicle and/or margin involvement with negative lymph nodes, 18 (33%); lymph node metastases, 12 (22%). Neither pre-therapy serum PSA nor serum PSA response was predictive of final pathological stage. With a median follow-up interval of 26 months (range 12-49), 21 patients (38%) have undetectable serum PSA without adjuvant therapy. CONCLUSIONS: Our results indicate that despite clinical evidence suggestive of downstaging, the majority of patients with locally advanced prostatic carcinoma managed with neoadjuvant DES and RRP continue to have pathological evidence of extraprostatic carcinoma.

Adenocarcinoma↗
PubMed1993

The role of neoadjuvant hormonal manipulation in localized prostatic cancer.

BACKGROUND: Although hormonal manipulation is standard therapy for patients with metastatic prostatic cancer, its use in localized disease in combination with surgical extirpation of the gland has not been investigated thoroughly and systematically. METHODS: The authors report their initial pilot studies using preoperative neoadjuvant endocrine therapy. RESULTS: Although marked reduction in serum prostate-specific antigen (PSA) levels occurred in all patients, the PSA level after endocrine manipulation did not predict the pathologic stage. In addition, immunohistochemical staining of the radical prostatectomy specimen for PSA, in several patients with a zero serum PSA level, after endocrine therapy revealed intense PSA staining in the cancer cells but not in benign epithelium. The effects on tumor downstaging were inconclusive. Overall, only 33% of patients had organ-confined disease, but in some patients, complete tumor regression (PO) occurred. CONCLUSIONS: Neoadjuvant hormonal therapy in prostatic cancer, although definitely not standard therapy, bears investigation. In addition to the effect on the "index" cancer, it also provides an opportunity to evaluate the effect of hormonal agents on microfocal ("early") cancer and known precursors of malignant change. Therefore, it may provide a means of assessing agents of potential use in the development of chemopreventive strategies.

Administration, Oral↗
PubMed1993

Secondary carcinoma of kidney from parotid gland tumor.

Secondary tumors of the kidney are rarely diagnosed during life. However they should be suspected in a patient with a primary malignancy of nonrenal origin and a renal mass. A case of parotid cancer metastatic to the kidney is presented. This case is unique because of its rarity, clinical presentation, and pathologic findings.

Adult↗
PubMed1993

Randomized trial of etoposide and cisplatin versus etoposide and carboplatin in patients with good-risk germ cell tumors: a multiinstitutional study.

PURPOSE: This multicenter, randomized phase III clinical trial evaluated the efficacy of etoposide plus carboplatin (EC) versus etoposide plus cisplatin (EP) in good-risk germ cell tumor (GCT) patients. PATIENTS AND METHODS: Between October 1986 and December 1990, 270 patients with good-risk GCTs were randomized to receive four cycles of either EP or EC. The etoposide dose in all patients was 100 mg/m2 on days 1 through 5. EP patients received cisplatin at 20 mg/m2 on days 1 through 5 and therapy was recycled at 21-day intervals. For EC patients, the carboplatin dose was 500 mg/m2 on day 1 of each cycle and the EC recycling interval was 28 days. RESULTS: Two hundred sixty-five patients were assessable: 131 patients treated with EC and 134 treated with EP. One hundred fifteen of 131 assessable patients (88%) treated with EC achieved a complete response (CR) versus 121 of 134 patients (90%) treated with EP (P = .32). Sixteen patients (12%) treated with EC relapsed from CR versus four patients (3%) treated with EP. Therefore, 32 patients (24%) who received carboplatin experienced an event (incomplete response [IR] or relapse) compared with 17 of 134 patients (13%) who received cisplatin (P = .02). At a median follow-up of 22.4 months, event-free and relapse-free survival were inferior for patients treated with EC (P = .02 and P = .005, respectively). No difference in overall survival was evident (P = .52). CONCLUSION: Two-drug therapy with EC using this dose and schedule was inferior to therapy with EP. Cisplatin remains as the standard platinum analog in the treatment of patients with good-risk GCTs. Carboplatin should be restricted to investigational trials in GCT.

Adolescent↗
PubMed1993

Use of neoadjuvant androgen deprivation therapy in clinically localized prostate cancer.

Radical prostatectomy is an excellent form of treatment of pathologically organ-confined prostatic carcinoma. However, most clinically localized prostatic cancers have pathologic evidence of extracapsular spread, limiting the effectiveness of radical surgery in curing this disease. To improve the organ-confined rate of prostate cancer, we studied the effect of preoperative or neoadjuvant androgen deprivation therapy (ADT). Our initial attempts focused on downstaging locally advanced tumors (T3) with neoadjuvant diethylstilbestrol (3 mg/d). Our study of 59 patients revealed that although there were significant clinical signs of downstaging, most patients still had extraprostatic disease. However, a subset of patients demonstrated marked pathologic regression, so we initiated a nonrandomized but controlled study of neoadjuvant ADT (goserelin acetate and flutamide for 3 months) followed by radical prostatectomy in patients with clinically localized prostate cancer. Of 72 control and 69 study patients, the rate of organ-confined disease was 48% and 74% (including 4% with no detectable residual carcinoma), respectively. In addition, the margin-positive rate was 33% and 10%, respectively. As demonstrated in the previous study, changes in serum prostate-specific antigen, transrectal ultrasonographic evaluations, and digital rectal examinations could not predict those patients with favourable pathology. Our results suggest that neoadjuvant ADT may improve the pathologic stage in some prostatic carcinomas and is worthy of further investigation in the efforts to augment the effectiveness of radical prostatectomy.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed1992

High-dose chemotherapy and autologous bone marrow rescue for patients with refractory germ cell tumors. Early intervention is better tolerated.

Therapy with high-dose carboplatin plus etoposide-based chemotherapy plus autologous bone marrow rescue (AUBMR) was administered to 29 patients with advanced germ cell tumors (GCT) refractory to cisplatin-based chemotherapy. Two groups of patients with refractory disease were treated. Sixteen patients had been identified as "poor risk" at diagnosis and had an inappropriately slow decline of serum tumor markers after two cycles of induction cisplatin-based therapy (Group A). In addition, 13 patients were treated who had never had a complete response (CR) or had relapses after ifosfamide-based salvage chemotherapy (Group B). Patients in Group A were treated with high-dose carboplatin etoposide, and patients in Group B received high-dose carboplatin, etoposide, and cyclophosphamide. Fifteen of 29 (52%) patients had a CR (9, Group A; 6, Group B). The patients in Group A had fewer hematologic toxic effects, and the median number of days from day 0 to a granulocyte count greater than 0.5/microliters was 16 and to a platelet count of more than 50/microliters was 15, compared with 22 days and 23 days in Group B, respectively. There were fewer episodes of culture-positive sepsis in Group A (12%) compared with Group B (26%), and the only treatment-related death occurred in Group B. Therapy with high-dose carboplatin plus etoposide-based chemotherapy plus AUBMR is effective for patients with GCT refractory to regimens of cisplatin with or without ifosfamide. Early use of high-dose chemotherapy reduces hematologic toxic effects and allows patients to start treatment in a more predictable fashion after cytoreduction, rather than when the disease is progressing rapidly.

Adult↗
PubMed1991

Salvage chemotherapy for patients with germ cell tumors. The Memorial Sloan-Kettering Cancer Center experience (1979-1989).

Twenty-eight of 124 (23%) advanced germ cell tumor (GCT) patients who were treated on four successive platin-based induction regimens and who failed to achieve a durable complete response (CR) remain alive (median follow-up, 50 months). An analysis of prognostic factors for response and survival was conducted on the 94 patients who received salvage chemotherapy. Survival and/or response to salvage therapy were significantly enhanced for patients with a prior CR to induction chemotherapy, treatment with a cisplatin-based salvage regimen, a testis primary site, a normal serum human chorionic gonadotropin level, a normal serum lactate dehydrogenase level, one site of metastasis, and an Indiana Class of 6 or less. Patients with a prior incomplete response (IR) had a particularly poor prognosis (P = 0.00007) with only 4 of 52 (9%) patients alive (median follow-up, 37 months) compared with 15 of 42 (36%) patients with a prior best response of a CR (median follow-up, 35 months). The poor survival of patients who fail to achieve a durable CR to induction chemotherapy warrants the continued investigation of new salvage therapy. The identification of prognostic features may direct salvage therapy and aid in the interpretation of clinical trials of salvage regimens.

Adolescent↗
PubMed1990

The role of ifosfamide plus cisplatin-based chemotherapy as salvage therapy for patients with refractory germ cell tumors.

A prospective study of four cycles of etoposide with ifosfamide and cisplatin (VIP) chemotherapy was conducted in 42 germ cell tumor (GCT) patients who were refractory to cisplatin with etoposide/vinblastine-based therapy. Forty patients were evaluable for response. Ten patients (25%) had a complete response: seven to chemotherapy alone and an additional three patients after surgical resection of viable GCT. With a median follow-up of 15 months, four complete responders relapsed, and six patients (15%) remain in remission. Hematologic and nephrotoxicity were moderately severe. Durable complete responses with VIP as second salvage were achieved and suggests that ifosfamide adds efficacy to standard first-salvage therapy. The observed nephrotoxicity and myelotoxicity are considerations in the design of ifosfamide-cisplatin-based regimens. Hematopoietic growth factors may be useful in ameliorating myelotoxicity. The early use of ifosfamide-based chemotherapy may reduce the nephrotoxicity exacerbated by prior cisplatin. A trial of VIP as first salvage after a relapse from a complete response to platinum-based induction therapy is warranted. The modest proportion of patients who achieve a durable remission to VIP as second salvage emphasizes the need for more efficacious salvage therapy for patients who do not achieve a durable complete response.

Adolescent↗
PubMed1989

Neo-adjuvant chemotherapy for invasive bladder cancer. Experience with the M-VAC regimen.

A series of 71 patients with muscle invasive bladder cancer received a median of 3 cycles (range 1-6) of methotrexate, vinblastine, Adriamycin and cisplatin (M-VAC). Efficacy assessed by transurethral resection alone showed that 48% of patients were TO, 13% Tis and 54% had normalisation of initially positive urinary cytology after treatment. However, when considering transurethral resection of the bladder (TURB), cytology and non-invasive procedures (CT scan and/or ultrasound), only 21% had a clinical complete remission (cCR); 48 patients (68%) had pathological evaluation and 13 (27%) were PO after treatment. Non-responding patients had a poor prognosis: 14/30 (47%) developed metastatic disease and 13 died. In assessing the primary lesions, clinical understaging was significant. Of 15 patients who were TO cystoscopically prior to surgery, 6 (40%) had residual disease in the pathological specimen, including 4 with muscle infiltration; 23 patients (32%) remained clinically staged, only 8 of whom remain disease-free. With a median follow-up of 24 months (range 2-42+), 41 patients are alive and disease-free, including 20 with a functional bladder. The large staging error raises questions concerning studies using clinical rather than pathological endpoints as the sole criteria of efficacy.

Adult↗
PubMed1988

Advanced seminoma: the role of chemotherapy and adjunctive surgery.

STUDY OBJECTIVE: To determine the effectiveness of chemotherapy and adjunctive surgery in managing patients with advanced seminoma. DESIGN: Nonrandomized prospective clinical trial of chemotherapy in a cohort of patients with advanced seminoma. SETTING: Referral cancer hospital. PATIENTS: Consecutive sample of 62 patients with primary extragonadal, stage IIC (greater than 5-cm retroperitoneal adenopathy) and stage III seminoma; 45 patients were previously untreated, 13 had received radiotherapy, and 4 had previously received radiotherapy and chemotherapy. INTERVENTION: Cisplatin-based chemotherapy (100 to 120 mg/m2 body surface area per cycle of treatment); 45 patients received vinblastine, bleomycin, cisplatin, dactinomycin, and cyclophosphamide; 15, etoposide and cisplatin; and 2, both regimens. MEASUREMENTS AND MAIN RESULTS: Fifty-three of the sixty (88%) evaluable patients achieved a complete remission, and only 6 patients had relapses. Fifty-three of the sixty-two patients (85%) remain alive and disease-free. The regimen of etoposide and cisplatin was equivalent to regimens using more drugs. An elevated level of human chorionic gonadotropin at the initiation of treatment was associated with a worse prognosis. CONCLUSIONS: Cisplatin-based chemotherapy is effective treatment for patients with extragonadal, stage IIC, and stage III seminoma and should be considered as initial therapy.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed1987

Alternating cycles of etoposide plus cisplatin and VAB-6 in the treatment of poor-risk patients with germ cell tumors.

A phase II trial of 6 months of alternating etoposide plus cisplatin (EP) and cyclophosphamide, vinblastine, actinomycin D, bleomycin, cisplatin (VAB-6) was conducted in 41 evaluable patients in an attempt to improve the treatment results in those patients considered to have "poor-risk" germ cell tumors (GCT). Eight of 14 (57%) patients with mediastinal and retroperitoneal GCTs achieved complete remission (CR), and five (36%) remain alive and free of disease. Fourteen of 27 patients (52%) with poor-risk testicular cancer achieved CR, and ten (37%) remain alive and free of disease. Two patients with seminoma, one each with a testicular and extragonadal primary tumor, achieved durable CRs. Toxicity was tolerable, but greater than that of VAB-6 alone. The response and survival of the 39 patients with nonseminomatous tumors were found to be identical to the results of 29 patients with nonseminomatous GCTs and poor-risk characteristics who were treated with VAB-6 alone. Thus, this 6-month schedule of alternating months of chemotherapy is not recommended for patients with poor-risk GCTs. Patients with such tumors should be referred to centers conducting prospective trials, so that research seeking better therapy may continue.

Adolescent↗
PubMed1987

Residual mass: an indication for further therapy in patients with advanced seminoma following systemic chemotherapy.

Forty-one advanced seminoma patients with normal biochemical markers and a complete or partial radiographic response after cisplatin-based chemotherapy had a complete reevaluation of all known sites of disease. Twenty-three patients had a residual mass, and in 14 the mass was greater than or equal to 3 cm. Nineteen patients with a residual mass, including 13 with a mass greater than or equal to 3 cm in diameter, had surgical excision or biopsy. Four patients had viable seminoma and one patient had teratoma; all five of these patients had residual masses greater than or equal to 3 cm. Four patients with a residual mass were observed without surgery. One patient with a residual mass greater than or equal to 3 cm progressed with biopsy-proven seminoma. Therefore, six of 14 patients (42%) with a residual mass greater than or equal to 3 cm had viable residual tumor. Eighteen patients had no residual mass after chemotherapy. Ten of these patients had surgery or biopsy; none had viable tumor, but two have relapsed. Eight patients were observed and none have relapsed. Advanced seminoma patients with a residual mass greater than or equal to 3 cm after chemotherapy are at high risk for residual viable tumor. Additional therapy is indicated for these patients. For patients with normal imaging studies or a residual mass less than 3 cm, close observation without surgery is generally possible.

Adult↗
PubMed1986

VAB-6: an effective chemotherapy regimen for patients with germ-cell tumors.

One hundred sixty-six patients with germ-cell tumors (GCT) of the testis, retroperitoneum, and mediastinum were treated with cyclophosphamide, vinblastine, bleomycin, dactinomycin, and cisplatin (VAB-6), with and without maintenance chemotherapy. The overall complete response (CR) rate was 78%, 67% to chemotherapy alone, and 11% after chemotherapy and resection of viable residual cancer. The CR rate in all patients with seminoma was uniformly high, while the CR rate of patients with testicular nonseminomatous germ-cell tumors (79%) was superior to that of similar tumors of extragonadal origin (60%). The overall relapse rate was 12%, and was greater in tumors of extragonadal origin (21%) than in those of testicular origin (11%). Three relapses occurred after 2 years. Maintenance chemotherapy did not prolong either relapse-free or total survival. Toxicity was tolerable, and there were no treatment deaths. No Raynaud's phenomena have occurred, with a minimum duration since start of therapy of 36 months. VAB-6 is an effective chemotherapy regimen in patients with GCT with no treatment-related deaths and a majority of patients requiring only 3 months of treatment.

Adolescent↗
PubMed1985

Role of etoposide-based chemotherapy in the treatment of patients with refractory or relapsing germ cell tumors.

Forty-nine patients with metastatic germ cell tumors were treated with etoposide 100 mg/m2 and cisplatin 20 mg/m2 intravenously each day for five days as "salvage" chemotherapy. Forty-seven patients had received standard induction regimens for metastatic germ cell tumors before receiving etoposide and cisplatin. Four patients were treated after surgical resection of a single site of relapse (Group I). Forty-five patients had measurable or evaluable disease at the time of treatment. In 17 patients with evaluable disease who had either achieved a prior complete remission or received no prior cisplatin (Group II), eight (47 percent) complete and four (24 percent) partial remission were observed. In 28 patients who had never achieved a prior complete remission (Group III), no complete and five (18 percent) partial responses were observed. Seven of 21 patients in Groups I and II and none of 28 patients in Group III remain alive and free of disease. Assuming prior treatment with cisplatin-based chemotherapy, these data and a review of the published experience with similar salvage regimens for patients with relapsing or refractory germ cell tumors suggest that combination chemotherapy based on etoposide and cisplatin is effective primarily in those patients who achieved a prior complete remission. Such therapy is ineffective in the absence of a prior complete remission probably because the patients have tumors that are largely resistant to cisplatin. Observed responses are probably due to etoposide alone. Investigational therapies should be pursued in those patients whose disease is refractory to current induction regimens.

Agranulocytosis↗