Search PubMed⌕ Search

Biomedical subjects

D F Bajorin

Publications and source records attributed to D F Bajorin.

At least 55 records · Page 3Linked to original sources
PubMed1997

Surgery for a post-chemotherapy residual mass in seminoma.

PURPOSE: We attempted to select patients for surgery of post-chemotherapy residual mass in advanced seminoma. MATERIALS AND METHODS: A total of 55 patients with advanced seminoma underwent surgical exploration of a mass seen on computerized tomography (CT) after chemotherapy. Residual masses were defined radiographically as smaller or larger than 3 cm. and as well defined or poorly defined. Surgery consisted of complete resection of the mass and surrounding lymph nodes or multiple biopsies at sites of disease. RESULTS: Of the 55 patients 32 (58%) had masses resected and 23 (42%) underwent multiple biopsies. Of 27 patients with a post-chemotherapy 3 cm. or larger mass on CT 8 (30%) had residual tumor (seminoma in 6 and teratoma in 2), whereas necrotic tissue was found in the other 28 patients having a mass smaller than 3 cm. Well defined masses on CT were resected in 78% of patients and poorly defined masses could be resected in only 44%. Of the 8 patients with positive histology 6 remain alive and disease-free after complete resection of a well defined, larger than 3 cm. mass containing viable tumor, and 2 with a poorly defined mass died after biopsy only of residual seminoma despite salvage therapy. Three other patients who underwent complete resection of necrotic masses subsequently had relapse at distant sites and died. Median followup was 47 months (range 5 +/- 153+ months). CONCLUSIONS: Patients with advanced seminoma who have a residual mass smaller than 3 cm. after chemotherapy do not benefit from surgery. For patients with a residual mass 3 cm. or larger we prefer surgery to define response, resect viable tumor when possible and direct further treatment.

Follow-Up Studies↗
PubMed1997

Germ cell tumors.

Explore the source record for details and available documents.

Adolescent↗
PubMed1997

Combined-modality therapy for bladder cancer.

Radical cystectomy remains standard management for patients with locally advanced T2 through T4, N0, M0 transitional cell carcinoma of the urinary bladder. Although radical cystectomy results in excellent local control, 50% or more of patients relapse. Studies have shown that multidrug cisplatin (Platinol)-based chemotherapy prolongs disease-free survival in 10% to 15% of cases and is superior to single-agent cisplatin. These studies led to the application of these regimens in conjunction with surgery and/or radiation therapy in an attempt to preserve bladder function. With this approach, the decision to leave the bladder in place, remove a portion (partial cystectomy), or perform a radical cystectomy is made after assessing the initial response to therapy. Results from neoadjuvant studies have shown that: major responses are observed in at least 50% of patients; bladder preservation can be achieved in 25% to 50%; a pathologic complete response predicts long survival; and patients with deeply invasive lesions (T3b to T4) usually are not candidates for bladder preservation. Whether overall survival is improved has been difficult to ascertain due to such issues as small sample size and case selection. Concurrently, newer surgical approaches with continent diversions have reduced, to some extent, the need for ileal conduits, a factor influencing the bladder preservation approach. Adjuvant chemotherapy, although less well studied, suggests a possible survival benefit for selected patients with a high likelihood of relapse. To optimize patients selection, new prognostic factors are necessary. Many biologic variables based on expression of tumor-related proteins are under study. Combined-modality therapy is not standard management for the majority of bladder-cancer patients. However, it is a viable alternative for those who are committed to preserving bladder function. Additional research is required to determine whether these approaches improve survival and to identify better markers of treatment outcome.

Carcinoma, Transitional Cell↗
PubMed1996

Resection of residual retroperitoneal masses in testicular cancer: evaluation and improvement of selection criteria. The ReHiT study group. Re-analysis of histology in testicular cancer.

Residual retroperitoneal masses may remain after chemotherapy for metastatic non-seminomatous testicular cancer, which harbour residual tumour or totally benign tissue (necrosis/fibrosis). These residual masses may be effectively removed by a surgical resection. We evaluated current selection criteria and tried to develop alternative criteria in a data set of 544 patients, who had retroperitoneal lymph node dissection of residual masses. Six resection policies were identified from the literature. Two alternative policies were developed with logistic regression analysis. Evaluation of the policies focused on the true-positive rate (resection in case of tumour), and the false-positive rate (resection in case of necrosis). It appeared that most current policies use the size of the residual mass (> or = 10 mm or > or = 20 mm) as the predominant selection criterion. This resulted in high true-positive rates (most > 90%), but false-positive rates between 37% and 87%. The alternative policies included five well-known predictors of necrosis in addition to residual mass size (primary tumour histology, prechemotherapy levels of the three tumour markers alphafetoprotein (AFP), human chorionic gonadotropin (HCG) and lactate dehydrogenase (LDH) and mass shrinkage during chemotherapy). This strategy resulted in improved true- and false-positive rates, even when categories of the predictors were simplified for practical application. We conclude that a simple statistical model, based on a limited number of patient characteristics, provides better guidelines for patient selection than those currently used in clinical practice.

Adult↗
PubMed1996

Methotrexate, vinblastine, doxorubicin and cisplatin chemotherapy and cystectomy for unresectable bladder cancer.

PURPOSE: We combined chemotherapy and surgery to improve local control and survival of patients with unresectable bladder cancer. MATERIALS AND METHODS: A total of 41 patients with unresectable bladder cancer (T4bNX/N + M0) received methotrexate, vinblastine, doxorubicin and cisplatin (M-VAC) chemotherapy followed by radical cystectomy when possible. End points were response to M-VAC, local control and survival. RESULTS: Minimum followup was 4 years (range 4 to 7). Of the 41 patients 14 (34%) achieved a complete (T0) and 27 (66%) achieved an incomplete (T+) clinical response to M-VAC, including 29 who underwent exploration and 24 who underwent cystectomy. Definitive surgery was not done in 17 patients due to lack of response to M-VAC with local or systemic tumor progression, or refusal. Nine patients (22%) are alive, including all but 1 after cystectomy for T0 disease, and 2 had T+ tumor confined to the bladder for longer than 5 years. None of the patients with no response or tumor progression on M-VAC survived. Resection of extravesical disease after M-VAC in 16 patients did not prolong survival or improve local tumor control. Six patients required laparotomy for palliation of tumor related complications. CONCLUSIONS: Our results suggest that patients who present with unresectable bladder cancer may benefit from M-VAC and definitive surgery, especially when disease is T0 and P0 status. Surgery may salvage select cases of advanced pelvic tumor down staged by chemotherapy to tumors pathologically confined to the bladder. Alternative treatment strategies are needed for the majority of patients with locally advanced bladder cancer.

Adult↗
PubMed1996

Management of residual mass in advanced seminoma: results and recommendations from the Memorial Sloan-Kettering Cancer Center.

PURPOSE: Guidelines for management of postchemotherapy residual mass in patients with advanced seminoma remain controversial. We sought to characterize independent prognostic factor(s) for persistence of tumor to identify patients with a high risk of residual carcinoma. PATIENTS AND METHODS: One hundred four patients with advanced seminoma were assessed. All had achieved a complete response or partial response with normal markers to induction cisplatin-based chemotherapy and had radiographs available for review. Selected prechemotherapy and postchemotherapy characteristics were compared for patients who had either germ cell tumor histology at surgery or relapsed at the assessed site (defined as site failure) versus those who had only necrosis or fibrosis found at surgery and did not relapse at the assessed site (defined as site nonfailure). RESULTS: At a median follow-up time of 47 months (range, 5 to 153), 94 patients (90%) were designated as site nonfailures and 10 (10%) as site failures. Site failure correlated only with size of the residual mass (< 3 cm or normal v > or = 3 cm; P = .0006). Two of 74 patients (3%) with residual masses less than 3 cm were considered site failures, compared with eight of 30 (27%) with residual masses > or = 3 cm. CONCLUSION: Patients with advanced seminoma who have normal radiographs or residual masses less than 3 cm after chemotherapy can be observed without further intervention. The following three options exist for patients with a residual mass > or = 3 cm: observation, radiotherapy, or surgical intervention. We prefer the latter to define response, resect viable tumor when possible, and direct further treatment.

Adolescent↗
PubMed1996

High-dose carboplatin, etoposide, and cyclophosphamide for patients with refractory germ cell tumors: treatment results and prognostic factors for survival and toxicity.

PURPOSE: The efficacy and toxicity of high-dose carboplatin, etoposide, and cyclophosphamide with autologous bone marrow transplantation (AuBMT) was investigated in a prospective trial for patients with cisplatin-refractory germ cell tumor (GCT). Prognostic factors for survival and treatment-related toxicity were identified. PATIENTS AND METHODS: Fifty-eight patients with refractory GCT were treated with high-dose carboplatin, etoposide, and cyclophosphamide plus AuBMT. Prognostic factors for toxicity and survival were examined in multivariate analyses. RESULTS: Twenty-three patients (40%) achieved a complete response and 12 (21%) are alive and free of disease at a median follow-up time of 28 months. Myelosuppression was severe and there were seven (12%) treatment-related deaths. Independently predictive factors that resulted in faster blood count recovery were the use of granulocyte colony-stimulating factor (G-CSF) for the number of days to neutrophil count recovery (P = .013) and prior treatment with cisplatin limited to six cycles or less for the number of days to platelet count recovery (P = .0012). Both were predictive for the number of days of hospitalization (P = .04 and .03, respectively). The two independently predictive variables for survival were pretreatment level of HCG; human chorionic gonadotrophin (HCG; < or = 100 times the upper limit of normal [xnl] v > 100 xnl, P = .02) and the presence of retroperitoneal metastases (yes or no, P = .04). Patients grouped by HCG < or = 100 xnl with retroperitoneal metastases, HCG < or = 100 xnl without retroperitoneal metastases, and all patients with HCG more than 100 xnl had median survival times of 14, 11, and 3 months, respectively (P = .04). CONCLUSION: High-dose carboplatin, etoposide, and cyclophosphamide is an effective therapy for patients with refractory GCT, and results in a complete response proportion of 40% and a 2-year survival rate of 31% at a median follow-up time of 28 months. This was accomplished in a group of patients with a dismal prognosis to conventional-dose therapy.

Adolescent↗
PubMed1996

Simultaneous retroperitoneal, thoracic, and cervical resection of postchemotherapy residual masses in patients with metastatic nonseminomatous germ cell tumors of the testis.

PURPOSE: We report our experience with simultaneous resection of residual masses above and below the diaphragm in patients with metastatic nomseminomatous germ cell tumor (NSGCT) of the testis. MATERIALS AND METHODS: Twenty-four patients underwent simultaneous resection of residual postchemotherapy masses in the retroperitoneum and chest, including three who also had radical neck dissection. All had been heavily pretreated with chemotherapy and five had undergone previous retroperitoneal lymph node dissections (RPLNDs). RESULTS: The combined procedure was performed with no mortality and low morbidity. The median length of the procedure was 5 hours 45 minutes, median blood loss 500 mL, and median length of hospital stay 9 days. Complications included one patient with chylous ascites and one with a prolonged air leak, both of which resolved with conservative management. Eighteen patients had similar pathologic findings in all sites: 13 with necrosis only and five with teratoma only. Six patients had discordant pathology in the abdomen and chest, including one with viable tumor in the chest only and two with viable tumor in the abdomen only. The overall actuarial 5-year survival rate for all patients was 79%. CONCLUSION: Simultaneous resection of neck, chest, and abdominal residual masses after chemotherapy for germ cell tumors is both a feasible and safe alternative to staged excision in selected patients who require surgical intervention at multiple sites and fulfills the objective of rendering patients disease-free in a single operative procedure.

Adolescent↗
PubMed1996

Phase I study of continuous-infusion recombinant macrophage colony-stimulating factor in patients with metastatic melanoma.

Macrophage colony-stimulating factor (M-CSF) is a lineage-specific, homodimeric growth factor that supports the proliferation and maturation of bone marrow progenitors and the survival and function of mononuclear/macrophage cells. In vitro studies have demonstrated antitumor activity of macrophage colony-stimulating factor-treated monocytes against melanoma target cells. A Phase I study was conducted by administering the glycosylated form of the protein to patients with metastatic melanoma as two 7-day continuous i.v. infusions separated by a 2-week rest. Cohorts of three patients per dose level received escalating doses of 10-160 microgram/kg/day. Safety, clinical, and biological effects were evaluated. The infusions were well tolerated with occasional maximum grade 2 nonhematological toxicity. Rapidly reversible thrombocytopenia was the major hematological adverse effect. Its etiology may in part be explained by proliferation and activation of monocyte/macrophage cells in bone marrow samples. Evidence for a biological effect on tumors was suggested by the delayed, complete disappearance of multiple lesions in one patient and a decrease in the size of one marker lesion in a second patient with a mixed response. Fasting serum cholesterol levels decreased during the infusions and may represent an additional therapeutic application for this growth factor.

Adult↗
PubMed1995

Phase III randomized trial of interleukin-2 with or without lymphokine-activated killer cells in the treatment of patients with advanced renal cell carcinoma.

BACKGROUND: Treatment with interleukin-2 (IL-2) and lymphokine-activated killer cells (LAK) resulted in responses in some patients with advanced renal cell carcinoma (RCC). However, the relative therapeutic benefit of the addition of LAK to IL-2 was unknown. METHODS: A randomized Phase III trial was conducted in patients with RCC comparing continuous intravenous infusion (CI) IL-2 alone with CI IL-2 plus LAK. Interleukin-2 was administered at 3 x 10(6) U/m2/day on days 1-5, 13-17, 21-24, and 28-31. Patients on the LAK treatment arm underwent leukapheresis on days 8-10 and LAK cell reinfusion on days 13-15. The results are reported with long-term follow-up. The published experience with IL-2 alone or with the addition of LAK was investigated in a quantitative literature survey. The response proportions were studied by schedule (high dose bolus, moderate dose, low dose) and by concomitant administration of LAK. RESULTS: Seventy-one patients were treated, 36 on the IL-2 arm and 35 on the IL-2 plus LAK arm. Four patients (6%) had major responses (two complete, two partial). The median survival of all patients was 13 months (95% confidence interval [CI], 9-18 months). There were no differences between treatment arms with regard to response (P = 0.61) and survival (P = 0.67). More patients on the LAK arm experienced pulmonary toxicity (P = 0.008). The overall weighted response proportion was 16% (95% CI, 8%-24%) for the 39 published series of 1291 patients treated with IL-2. The 95% confidence intervals for response proportion overlapped when compared by schedule and by administration of LAK. CONCLUSIONS: The dose and schedule of IL-2 used in this study resulted in a low level of antitumor activity and the addition of LAK did not improve the response rate against RCC. Given the infrequent, but reproducible, responses with IL-2 and interferon-based regimens, continued investigation of these agents is warranted as is the study of new cytokines. Alternative treatment strategies should be studied in RCC and new agents and treatment regimens that appear promising in Phase II studies must be studied in randomized trials.

Adult↗
PubMed1995

Phase II trial of topotecan in patients with cisplatin-refractory germ cell tumors.

Fifteen patients with advanced, cisplatin-refractory germ cell tumors (GCT) were treated on a phase II trial with topotecan. None of the 14 evaluable patients achieved a complete or partial response. Myelosuppression was the major toxicity. The median nadir leukocyte count was 1.75 cells/mm3, neutrophil count was 1.55 cells/mm3, hemoglobin was 8.75 gm/dl, and platelet count was 20,500 cells/mm3. Topotecan is not efficacious in the treatment of cisplatin-refractory GCT.

Adult↗
PubMed1995

Recombinant human granulocyte-macrophage colony-stimulating factor as an adjunct to conventional-dose ifosfamide-based chemotherapy for patients with advanced or relapsed germ cell tumors: a randomized trial.

PURPOSE: Ifosfamide-containing therapy with cisplatin plus either etoposide (VIP) or vinblastine (VeIP) can cure of patients with relapsed germ cell tumors (GCTs), but results in substantial myelotoxicity. This study sought to assess the impact of recombinant human granulocyte-macrophage colony-stimulating factor (rhGM-CSF) on the severity of neutropenia and incidence of infectious complications in patients who receive ifosfamide-based chemotherapy for GCT. PATIENTS AND METHODS: One hundred and four assessable GCT patients from 20 centers were randomized to receive rhGM-CSF with either cycles 1 and 2 or cycles 3 and 4 of chemotherapy. Standard doses of VIP or VeIP were used. Efficacy data were analyzed using a parallel design for cycles 1 and 2 before the crossover. RESULTS: Fewer clinically relevant infections occurred in rhGM-CSF patients (13 of 55, 24%) versus observation patients (22 of 49, 45%) in cycle 1 (P = .01). Decreases were observed in infections during neutropenia (22% v 43%, P = .03), infections requiring intravenous antibiotics (20% v 43%, P = .01), and any infection irrespective of severity (29% v 55%, P = .01) in cycle 1. However, there were no significant differences among the treatment arms in cycle 2 in the proportion of clinically relevant infections (P = .23), infections associated with neutropenia (P = .11), infections requiring antibiotics (P = .22), or any infection (P = .65). rhGM-CSF was discontinued in 14% of cycles because of toxicity related to the growth factor. CONCLUSION: rhGM-CSF reduced the incidence of infections in the first cycle of chemotherapy, but no benefit beyond the initial chemotherapy cycle was evident. Based on the limited clinical impact and the high incidence of rhGM-CSF-related toxicity that required growth factor discontinuation, the routine administration of rhGM-CSF to prevent neutropenia and infection after ifosfamide-based chemotherapy for GCT patients is not recommended.

Adolescent↗
PubMed1995

Etoposide and cisplatin adjuvant therapy for patients with pathologic stage II germ cell tumors.

PURPOSE: Two options cure nearly all patients with pathologic stage II nonseminomatous germ cell tumors (NSGCTs): two cycles of adjuvant chemotherapy with cisplatin, vinblastine, and bleomycin (PVB) or cisplatin, vinblastine, bleomycin, cyclophosphamide, and dactinomycin (VAB-6); or close observation with full treatment at relapse. Two cycles of etoposide plus cisplatin (EP) were given to selected patients with pathologic stage II NSGCT and high-volume nodal metastases. PATIENTS AND METHODS: All patients had pathologic stage II NSGCT with one or more of the following features found at retroperitoneal lymph node dissection (RPLND), suggesting a greater than 50% likelihood of relapse after observation alone: (1) any lymph node involved by tumor greater than 2 cm (stage N2b); (2) > or = six nodes involved with tumor (stage N2b); and (3) extranodal extension (stage N3). Two cycles of therapy were given at 21-day intervals; each cycle consisted of etoposide 100 mg/m2 plus cisplatin 20 mg/m2 per day given on days 1 to 5. RESULTS: Fifty patients were treated with two cycles of EP. Treatment was well tolerated; five patients (10%) were admitted for nadir fever and none had grade II or greater neurologic, renal, or pulmonary toxicity. All 50 patients are alive and relapse-free at a median follow-up time of 35 months (range, 12 to 72). The follow-up duration has been > or = 2 years for 42 patients. CONCLUSION: A treatment program that consists of two cycles of EP is effective in preventing relapses in patients with completely resected pathologic stage N2b and N3 NSGCT. The likelihood of relapse without adjuvant cisplatin-containing chemotherapy in this group has been shown to be greater than 50%. As has been demonstrated in patients with disseminated germ cell tumor (GCT), EP can be considered a therapeutic option in the adjuvant setting for completely resected N2b and N3 NSGCT.

Adolescent↗
PubMed1995

Prognostic value of p53 nuclear overexpression in patients with invasive bladder cancer treated with neoadjuvant MVAC.

PURPOSE: This study sought to examine the prognostic role of p53 nuclear overexpression in muscle-invasive bladder cancer because of its correlation with progression of superficial bladder cancer. PATIENTS AND METHODS: Ninety of 111 patients treated with neoadjuvant methotrexate, vinblastine, doxorubicin, and cisplatin (MVAC) with a median follow-up duration of 5.8 years were evaluated. p53 nuclear overexpression was determined by immunohistochemistry on deparaffinized tissue sections. Patients were stratified into two groups according to the percent of tumor cells with positive nuclear reactivity. Overexpression was defined as tumors with > or = 20% cells with positive nuclear reactivity and nonoverexpression as tumors with less than 20% reactivity. RESULTS: Nuclear overexpression was observed in 47 patients and nonoverexpression in 43 patients. Patients whose tumors had p53 overexpression had a significantly higher proportion of cancer deaths. A multivariate analysis that evaluated the pretreatment variables p53 nuclear overexpression, age, sex, palpable mass, prechemotherapy tumor stage, performance status, ureteral obstruction, tumor size, multifocality, and grade showed that p53 overexpression had independent significance for survival (P = .001; relative risk ratio, 3.1). The impact of p53 overexpression on survival was predominantly in T2 and T3a tumors. Long-term survival was evident in seven of 17 patients (41%) with p53 overexpression versus 20 of 26 (77%) in whom p53 was not overexpressed (P = .007). CONCLUSION: p53 nuclear overexpression has independent prognostic value for survival in patients with invasive bladder cancer treated with neoadjuvant chemotherapy.

Adult↗
PubMed1995

Paclitaxel in germ cell cancer.

The teratocarcinoma cell line 833K and its relatively cisplatin-resistant subline 833K/63CP 10 were used to assess the cytotoxicity of paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ), cisplatin, and 4-hydroxyperoxycyclophosphamide quantitatively. The results showed that paclitaxel had marked cytotoxicity against teratocarcinoma, particularly in the cells that were relatively cisplatin resistant. These studies suggested synergy in cytotoxicity for paclitaxel, cisplatin, and 4-hydroxyperoxycyclophosphamide. A phase II trial of paclitaxel was conducted in patients with previously treated germ cell tumors with restricted prior treatment. The paclitaxel dose was 250 mg/m2 given by 24-hour continuous infusion. In 31 patients treated with paclitaxel, eight (26%) achieved a major (complete or partial) response. The antitumor activity of paclitaxel in the phase II trial has led us to further study it as a part of combination therapy. Since the in vitro studies showed synergistic cytotoxicity, combination studies of paclitaxel, ifosfamide, and platinum are under way as salvage treatment for patients with germ cell tumors.

Adolescent↗
PubMed1994

Resection of postchemotherapy residual masses and limited retroperitoneal lymphadenectomy in patients with metastatic testicular nonseminomatous germ cell tumors.

BACKGROUND: Adjunctive retroperitoneal lymphadenectomy (RPLND) plays an important role in the management of patients with metastatic nonseminomatous germ cell tumors (NSGCT). Currently, a bilateral RPLND is recommended for residual disease after chemotherapy. METHODS: The authors systematically have removed all residual masses and used intraoperative frozen section analysis to dictate the extent of surgery in the patients with NSGCT: If frozen section revealed necrosis, then a limited RPLND was performed; otherwise, a bilateral RPLND was attempted. RESULTS: Forty patients with metastatic NSGCT were studied. Of the 40 patients, 21 had necrosis identified in frozen section analysis of the residual mass(es), with 18 (85.7%) confirmed in permanent section. Two patients had microscopic viable germ cell tumor, and one had microscopic teratoma in the residual mass with the remaining RPLND specimen tumor-free. Overall, 18 of 45 patients (45%) had necrosis, 17 (42.5%) had teratoma, and 5 (12.5%) had viable germ cell tumor, identified in permanent section analysis. The median follow-up period was 36 months (range, 24-60 months). Of the 40 patients, 8 (20%) experienced recurrences, although none were in the retroperitoneum; 5 were chest recurrences (4 germ cell, 1 teratoma), 2 were retrocrural recurrences (teratomas), and 1 recurrence was with liver metastasis. Of the tumors of the 21 patients with frozen section analysis showing necrosis who underwent resection of residual mass(es) and limited RPLND, 3 (14.3%) experienced recurrences; 2 had germ cell tumors in the chest, and 1 had liver metastasis. The remaining 18 (85.7%) patients had no evidence of disease, with a mean follow-up of 33 months (range, 24-60 months). CONCLUSIONS: These results suggest that in patients with metastatic NSGCT of the testis, postchemotherapy resection of all retroperitoneal masses followed by limited RPLND if frozen section analysis shows only necrosis is a safe alternative to a difficult, potentially morbid bilateral dissection.

Adolescent↗
PubMed1994

Bladder cancer: advances in biology and treatment.

Integrating systemic chemotherapy in the treatment of patients with invasive bladder cancer is essential to improve survival because the majority of deaths are from systemic relapse. However, as experience with invasive tumors evolves, it is clear that treatment recommendations need to be tailored to an individual patient based on metastatic risk and, ideally, sensitivity to treatment. For those with tumors that do not extend through the bladder wall, standard therapy remains radical surgery. Nevertheless, encouraging results are being reported with increasing frequency using strategies designed to preserve bladder function through a variety of means. Crucial to the recommendation of a specific approach for an individual is improving our ability to define prognosis prior to initiating treatment. Patients with a high risk of systemic recurrence generally require chemotherapy, although the optimal route of integration, pre vs. post-operatively, remains controversial. In those patients who require it, chemotherapy can be administered more safely with the concomitant administration of hematopoietic growth factors. These factors alone, however, are unlikely to improve overall survival. Crucial to the latter effort will be the identification of more active agents, improving our understanding of intrinsic and acquired resistance to chemotherapy, and better delivery of the chemotherapeutic agents currently available. Of equal importance, is the enrollment of patients in clinical trials. These can include large scale randomized comparisons with using a survival end-point, as well as new therapies in high risk populations. The latter would include patients with advanced T3b, T4 and N+ disease, with a high risk of metastatic failure, and low complete response proportions to presently available regimens.

Antineoplastic Agents↗