B cells in rheumatology--transforming thinking in rheumatoid arthritis.
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Antibodies, Monoclonal↗
Biomedical subjects
J D Hainsworth
Publications and source records attributed to J D Hainsworth.
Panel discussion on B cells and rituximab: mechanistic aspects, efficacy and safety in rheumatoid arthritis and non-Hodgkin's lymphoma.
The clinical potential of rituximab (MabThera/Rituxan), a selective B-cell-depleting agent, in the treatment of patients with rheumatoid arthritis (RA) is rapidly becoming apparent. The data presented at an official satellite symposium of the European League Against Rheumatism (EULAR) Congress (2003, Lisbon, Portugal), reinforce the rationale for the use of this novel agent in RA and have provided an early indication of its clinical efficacy, safety and tolerability. The symposium presentations were followed by a panel discussion and a question and answer session in which the participants were able to shed further light on specific mechanistic issues relating to effects on B-cell populations based on available data and their own clinical experience of rituximab. Additionally, the implications of current results for longer-term clinical efficacy and safety were discussed. It is becoming clear that rituximab (alone or in combination with disease-modifying anti-rheumatic drugs) is highly efficacious in RA. Extensive data from patients with non-Hodgkin's lymphoma show that early concerns over increased infection rates due to prolonged suppression of B cells have not been realized. The effects of rituximab on long-term RA outcomes, such as joint erosion and duration of response (particularly in patients receiving combination therapy), are eagerly anticipated.
Antibodies, Monoclonal↗
Weekly docetaxel with either gemcitabine or vinorelbine as second-line treatment in patients with advanced nonsmall cell lung carcinoma: Phase II trials of the Minnie Pearl Cancer Research Network.
BACKGROUND: The current study was conducted to evaluate the feasibility, toxicity, and efficacy of weekly docetaxel when paired with either gemcitabine or vinorelbine as the second-line treatment of patients with advanced nonsmall cell lung carcinoma. METHODS: Patients with progressive nonsmall cell lung carcinoma after one previous chemotherapeutic regimen, an Eastern Cooperative Oncology Group performance status of 0-2, and measurable lesions were eligible for treatment in these Phase II trials. Patients who had not received gemcitabine previously were treated with docetaxel, 30 mg/m(2), and gemcitabine, 800 mg/m(2), both of which were administered intravenously (i.v.) on Days 1, 8, and 15 of a 28-day cycle. If the patients had received gemcitabine as part of first-line therapy, they were treated with docetaxel, 30 mg/m(2), and vinorelbine, 20 mg/m(2) i.v., on Days 1, 8, and 15 of a 28-day cycle. Patients were reevaluated after two courses of treatment, and responding patients continued treatment for six courses or until disease progression. RESULTS: Forty patients were treated with a combination of docetaxel and gemcitabine, and 23 patients received docetaxel and vinorelbine. The docetaxel/gemcitabine combination was reasonably well tolerated, with moderate myelosuppression and a few nonhematologic toxicities reported. The objective response rate was 10%, with a 1-year survival rate of 20%. The docetaxel/vinorelbine combination was found to be poorly tolerated, with Grade 3/4 leukopenia reported in 71% of patients and neutropenic fever reported in 70% of patients despite frequent dose reductions and omission of the Day 15 doses. Enrollment onto this regimen was stopped prematurely due to toxicity, and after no major responses were observed in the first 20 evaluable patients. CONCLUSIONS: The combination of weekly docetaxel/gemcitabine appears to be feasible and relatively well tolerated as second-line treatment in patients with advanced nonsmall cell lung carcinoma, whereas a weekly combination of docetaxel and vinorelbine did not appear to be tolerable at the doses and schedule used in the current study. Neither regimen showed a level of activity that suggested any advantage compared with the results obtained with single-agent docetaxel in this setting.
Adult↗
Paclitaxel and carboplatin adjuvant therapy alone or with radiotherapy for resected nonsmall cell lung carcinoma: a feasibility study of the Minnie Pearl Cancer Research Network.
BACKGROUND: The objective of this study was to determine the feasibility and toxicity of paclitaxel and carboplatin given in the adjuvant setting alone for patients with resected Stage IB disease and combined with radiotherapy for patients with resected Stages II and IIIA disease and selected patients with Stage IIIB and IV disease (Revised International System for Staging of Lung Cancer). METHODS: One hundred two patients with resected nonsmall cell lung carcinoma were treated in the postoperative period with 3 courses of paclitaxel 200 mg/m(2) intravenously (i.v.) over 1 hour and carboplatin area under the curve of 6 i.v. every 3 weeks for 3 courses. Patients with Stage IB received no further therapy, and those with higher stages also subsequently received radiotherapy plus concurrent weekly paclitaxel and carboplatin over 6 weeks. The median age was 61 years, with 56 men and 46 women, and the predominant histologic type was adenocarcinoma. Twenty pneumonectomies, 80 lobectomies, and 2 other procedures were performed. Ninety percent of the patients (92 of 102) received all 3 courses of adjuvant paclitaxel and carboplatin (84% received full doses). Seventy-three percent received full doses of radiotherapy and concurrent weekly chemotherapy (49 of 67 patients), and 14 others received greater than 75% of the radiotherapy and concurrent chemotherapy. RESULTS: Toxicity of the chemotherapy was mild with only three hospitalizations for neutropenia and fever and no treatment-related deaths. Severe hypersensitivity occurred in six patients (6%). Concurrent radiation therapy and weekly chemotherapy also was well tolerated with the exception of Grade 3-4 esophagitis observed in 27% (17 of 67 patients). Follow-up was short with a median of 10 months, and 65% of all patients remained progression free. CONCLUSIONS: Three courses of paclitaxel and carboplatin is tolerable, feasible, and can be delivered in most patients in the adjuvant setting. Subsequently, in higher stage patients, concurrent postoperative radiation therapy and weekly paclitaxel and carboplatin is well tolerated and delivered in most patients. Definitive prospective randomized Phase III adjuvant trials are warranted.
Adult↗
Paclitaxel, carboplatin, and long-term continuous infusion of 5-fluorouracil in the treatment of advanced squamous and other selected carcinomas: results of a Phase II trial.
BACKGROUND: The purpose of this study was to evaluate the feasibility, toxicity, and efficacy of the combination of paclitaxel, carboplatin, and long-term continuous infusion 5-fluorouracil (5-FU) in the treatment of advanced squamous carcinomas of various primary sites. METHODS: Patients were eligible for this trial if they had metastatic squamous carcinoma at any site except the lung. In addition, patients with locally advanced squamous carcinoma of the head and neck were eligible, if they were considered unlikely to be cured with combined modality therapy. Sixty patients entered this trial between February 1995 and March 1999; 12 patients (20%) had received 1 previous chemotherapy regimen, whereas 48 patients (80%) were previously untreated. All patients received the following regimen: paclitaxel 200 mg/m(2), 1-hour intravenous infusion, Days 1 and 22; carboplatin area under the concentration-time curve (AUC) 6.0 intravenously, Days 1 and 22; 5-FU 225 mg/m(2)/day, by 24-hour continuous intravenous infusion, Days 1-35. Treatment courses were repeated at 6-week intervals; responding patients continued treatment for a maximum of 4 courses (24 weeks). RESULTS: Thirty-nine of 60 patients treated (65%) had objective responses to this regimen, with 25% complete responses. Twelve patients (22%) remain progression free from 7 to 63 months (median, 35 months) after completion of therapy. Complete responses were observed in squamous carcinomas from various primary sites including head and neck, esophagus, cervix, vagina, anus, and unknown primary. The most frequent Grade 3/4 toxicities observed with this 3-drug regimen included leukopenia (48%), diarrhea (17%), mucositis (28%), and portacath-related events (13%). CONCLUSIONS: The combination of paclitaxel, carboplatin, and long-term infusional 5-FU is feasible, well tolerated, and highly efficacious in patients with advanced squamous carcinomas of various primary sites. This regimen merits further investigation.
Adult↗
Weekly docetaxel in the treatment of elderly patients with advanced breast cancer: a Minnie Pearl Cancer Research Network phase II trial.
PURPOSE: To evaluate the efficacy and toxicity of docetaxel administered weekly to elderly or poor-performance status patients with advanced breast cancer. PATIENTS AND METHODS: Forty-one patients with advanced breast cancer who were either over the age of 65 or considered to be poor candidates for combination chemotherapy received docetaxel 36 mg/m2 weekly for 6 consecutive weeks, followed by 2 weeks without treatment. The median age of patients in this trial was 74 years, and 73% of patients had one or more visceral sites of metastases. Seventy-five percent of patients received weekly docetaxel as first-line treatment for metastatic breast cancer, and the other 25% received it as second-line treatment. Thirty-six patients were assessable for efficacy, and all patients were assessed for toxicity. RESULTS: A total of 448 doses of weekly docetaxel were administered to 41 patients. Thirteen patients (36%) had objective responses to treatment, and an additional 13 patients (36%) had stable disease or minor response. Median time to progression for responding and stable patients was 7 months (range, 3 to 27 months). Median survival for the entire group was 13 months, with 1- and 2-year actuarial survival rates of 61% and 29%, respectively. Severe neutropenia occurred in only 0.4% of courses, and no other hematologic toxicity was observed. Grade 3/4 fatigue was the most common toxicity, occurring in 20% of patients. CONCLUSION: Weekly docetaxel therapy is active and well tolerated by elderly and/or poor-performance status patients with advanced breast cancer. This treatment can be administered with minimal myelosuppression. Weekly docetaxel provides an additional option for treatment in this difficult subgroup of patients with metastatic breast cancer. Well-tolerated combination regimens containing weekly docetaxel merit evaluation for this patient population.
Aged↗
Paclitaxel and gemcitabine chemotherapy for advanced transitional-cell carcinoma of the urothelial tract: a phase II trial of the Minnie pearl cancer research network.
PURPOSE: To evaluate the toxicity and efficacy of combination chemotherapy with paclitaxel and gemcitabine in patients with advanced transitional-cell carcinoma of the urothelial tract. PATIENTS AND METHODS: Fifty-four patients with advanced unresectable urothelial carcinoma entered this multi-centered, community-based, phase II trial between May 1997 and December 1999. All patients were treated with paclitaxel 200 mg/m(2) by 1-hour intravenous (IV) infusion on day 1 and gemcitabine 1,000 mg/m(2) IV on days 1, 8, and 15; courses were repeated every 21 days. Patients who had objective response or stable disease continued treatment for six courses. RESULTS: Twenty-nine of 54 patients (54%; 95% confidence interval, 40% to 67%) had major responses to treatment, including 7% complete responses. With a median follow-up of 24 months, 16 patients (30%) remain alive and nine (17%) are progression-free. The median survival for the entire group was 14.4 months; 1- and 2-year actuarial survival rates were 57% and 25%, respectively. Seven (47%) of 15 patients previously treated with platinum-based chemotherapy responded to paclitaxel/gemcitabine. Grade 3/4 toxicity was primarily hematologic, including leukopenia (46%), thrombocytopenia (13%), and anemia (28%). Ten patients (19%) required hospitalization for neutropenia and fever, and one patient had treatment-related septic death. CONCLUSION: The combination of paclitaxel and gemcitabine is active and well tolerated in the first- or second-line treatment of patients with advanced transitional-cell carcinoma of the urothelial tract. Response rate and duration compare favorably with those produced by other active, first-line regimens. This regimen should be further evaluated in phase II and III studies, as well as in patients with compromised renal function.
Actuarial Analysis↗
Germ cell neoplasms and other malignancies of the mediastinum.
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Adolescent↗
Gemcitabine in the second-line therapy of patients with carcinoma of unknown primary site: a phase II trial of the Minnie Pearl Cancer Research Network.
The purpose of this study was to evaluate the activity of single-agent gemcitabine in previously treated patients with carcinoma of unknown primary site. Between January 1997 and October 1998, 39 patients were enrolled in this multicenter Phase II trial performed in the Minnie Pearl Cancer Research Network. Twenty-seven patients (69%) had adenocarcinoma or poorly differentiated adenocarcinoma; 35 patients (90%) had previously received treatment with chemotherapy regimens containing both a platinum agent and a taxane. Only 21% of patients had ever responded to previous therapy. Gemcitabine 1000 mg/m2 was administered intravenously on days 1, 8, and 15 of each 28-day course. Three of 36 evaluable patients (8%) had partial responses, and 9 patients (25%) had minor responses or stable disease with improved symptoms. The median time to progression for patients with partial responses or stable disease/improved symptoms was 5 months. Treatment was well tolerated, with uncommon grade 3 or 4 toxicity. Gemcitabine produced a low objective response rate in this refractory patient population, although approximately one-third of patients experienced symptomatic improvement. Treatment with gemcitabine was well tolerated. Because gemcitabine has activity against a variety of adenocarcinomas, further evaluation of this agent as part of first-line therapy for patients with carcinoma of unknown primary site is appropriate.
Adenocarcinoma↗
Docetaxel (Taxotere) in combination with radiation therapy and the potential of weekly administration in elderly and/or poor performance status patients with advanced non-small cell lung cancer.
A randomized phase II trial conducted by the Cancer and Leukemia Group B in patients with unresectable non-small cell lung cancer showed that induction chemotherapy followed by concurrent radiotherapy and chemotherapy was feasible when cisplatin was administered together with either gemcitabine, vinorelbine, or paclitaxel. The dominant toxicity was esophagitis. Preliminary survival data are encouraging. Other trials in progress or planned will elucidate the relative contributions of induction and concurrent therapy to outcome. A phase I study has shown that it is feasible to combine docetaxel (Taxotere: Aventis, Antony, France) with concomitant radiotherapy in patients with advanced non-small cell lung or esophageal cancer. Giving the drug once every 3 weeks during standard radiotherapy, the maximum tolerated dose is 40 mg/m2 per cycle. The dose-limiting toxicities are neutropenia and esophagitis. However, it is possible to escalate the total docetaxel dose to 60 mg/m2 per cycle by weekly administration of 20 mg/m2. Beyond this point, esophagitis is dose limiting. In the palliative-intent treatment setting, the weekly administration of docetaxel is also likely to be a helpful new approach to administering the drug in subgroups of patients such as the elderly and those with concomitant disease. Weekly docetaxel (36 mg/m2/wk) was administered to patients with advanced non-small cell lung cancer who were elderly (median age, 71 years) or had poor performance status. In this unfavorable group, weekly docetaxel produced a 19% objective response rate and with further follow-up, 1-year survival is 28%. This level of activity is similar to other single agents recently evaluated in more favorable patient groups. The lack of myelosuppression seen with weekly administration suggests that the dose intensity of docetaxel could be maintained in combination regimens.
Aged↗
Weekly docetaxel as a single agent and in combination with gemcitabine in elderly and poor performance status patients with advanced non--small cell lung cancer.
Administering docetaxel weekly at a relatively low dose minimizes myelosuppression and reduces nonhematologic toxicities. In a community-based phase II trial conducted in 39 elderly or poor performance status patients with advanced non--small cell lung cancer, weekly 36 mg/m(2) docetaxel produced a response rate of 20%. The response rate was 26% in patients with an Eastern Cooperative Oncology Group performance status of 0 or 1. Actual 1-year survival was 28% and actuarial 2-year survival was 15%. These results are similar to those achieved with other active single agents. The regimen of weekly docetaxel used was associated with minimal hematologic toxicity. There were no cases of grade 4 leukopenia, febrile neutropenia, toxicity-related hospital admissions, or treatment-related death. Nonhematologic toxicities were also mild, even in performance status 2 patients. In a subsequent phase II trial, a similar group of patients received weekly docetaxel at 30 mg/m(2) plus weekly gemcitabine 800 mg/m(2), both drugs given on days 1, 8, and 15 every 28 days. Preliminary analysis of data for the first 41 patients enrolled show an objective response rate of 29%, with an additional 45% of patients having stable disease. Although 26% of patients missed the day 15 dose of gemcitabine and docetaxel because of myelosuppression, the combination regimen was generally well tolerated. There were no hospitalizations caused by complications of myelosuppression. One patient developed bilateral pulmonary infiltrates, possibly treatment-related, and died of respiratory failure. Further evaluation of weekly docetaxel-based combinations is indicated. Semin Oncol 28 (suppl 9):21-25.
Aged↗
Paclitaxel-based three-drug combinations for the treatment of small cell lung cancer: a review of the Sarah Cannon Cancer Center experience.
Between June 1993 and September 1999, 217 patients with small cell lung cancer (SCLC) entered three sequential phase II trials evaluating novel paclitaxel-containing three-drug combination chemotherapy regimens. Patients with limited- or extensive-stage SCLC, no previous treatment, and Eastern Cooperative Oncology Group performance status 0 to 2 were eligible. Trials 1 and 2 evaluated the combination of paclitaxel, carboplatin, and etoposide; in the second trial, doses of paclitaxel and carboplatin were higher than in the first trial. Trial 3 evaluated the combination of paclitaxel, carboplatin, and topotecan. Patients with limited-stage disease received radiation therapy to the primary tumor site and mediastinum, beginning concurrently with the third course of chemotherapy. All patients received four courses of chemotherapy, administered at 21-day intervals. All three regimens were highly active and produced high response rates in both limited- and extensive-stage SCLC. Median survivals for regimens 1, 2, and 3 in extensive-stage patients were 8, 10, and 8.5 months, respectively. Median survivals in limited- stage disease were 16, 20, and 15 months, respectively. Although definitive comparisons of these regimens cannot be made on the basis of sequential trials, the higher-dose paclitaxel/carboplatin/etoposide regimen seemed superior; with this regimen, 4-year survival in limited-stage disease was 23%. Paclitaxel-containing three-drug regimens, as evaluated in these three phase II trials, were feasible and highly active in the first-line treatment of SCLC. Randomized trials will be necessary to definitively evaluate the efficacy of these regimens as compared with traditional platinum/etoposide combinations. Semin Oncol 28 (suppl 4):43-47.
Antineoplastic Combined Chemotherapy Protocols↗
Carcinoma of unknown primary site.
BACKGROUND: The long term survival and toxicity associated with the chemotherapy combination of paclitaxel, carboplatin, and extended-schedule etoposide used for the treatment of patients with metastatic carcinoma of unknown primary site were evaluated. METHODS: Seventy-one patients were treated between March 1995 and November 1996 with paclitaxel, carboplatin, and oral etoposide every 21 days. Stable or responding patients received four to eight courses of therapy. The following histologies were represented: well differentiated adenocarcinoma (34 patients); poorly differentiated adenocarcinoma or poorly differentiated carcinoma (30 patients); poorly differentiated neuroendocrine carcinoma (6 patients); and squamous cell carcinoma (1 patient). RESULTS: Forty-eight percent of assessable patients had major responses to therapy (95% confidence interval, 39%-55%), and 10 patients (15%) had complete responses. There were no response differences among the major histologic types. The median survival for all 71 patients was 11 months, and the 1-year, 2-year, and 3-year survival rates were 48%, 20%, and 14%, respectively. The minimum follow-up period was 34 months (range, 34-50 mos). The regimen was tolerated well with no treatment-related deaths and only 12 hospitalizations for neutropenia and fever. There was no serious long term toxicity. CONCLUSIONS: In this large Phase II trial, the combination of paclitaxel, carboplatin, and oral etoposide produced major responses or stable disease status in nearly 80% of patients who had carcinoma of unknown primary site. The median survival and 1-year, 2-year, and 3-year survival rates were noteworthy. The current study obtained similar or superior results to those seen with chemotherapy for many other groups of patients, such as those who had well defined advanced malignancies, those who were considered to have responsive tumors, and those who had obtained substantial benefits from cytotoxic therapy. Although the regimen reported in the current study can become an attractive option for many patients with carcinoma of unknown primary site, there remains a need for further clinical trials.
Adult↗
Paclitaxel for limited-stage small-cell lung cancer.
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Antineoplastic Agents, Phytogenic↗
Weekly docetaxel in the treatment of elderly patients with advanced nonsmall cell lung carcinoma. A Minnie Pearl Cancer Research Network Phase II Trial.
BACKGROUND: Weekly administration of docetaxel was found to reduce myelosuppression and other nonhematologic toxicities when compared with administration every 3 weeks. In the current Phase II trial, the authors evaluated the feasibility, toxicity, and efficacy of weekly docetaxel in the treatment of elderly patients with newly diagnosed advanced nonsmall cell lung carcinoma. METHODS: Thirty-nine patients with advanced, previously untreated nonsmall cell lung carcinoma entered this Phase II trial between February 1998 and January 1999. Patients were required either to be age >/= 65 years or to be poor candidates for combination chemotherapy due to coexistent medical illnesses. All patients received docetaxel, 36 mg/m(2), administered weekly for 6 consecutive weeks, followed by 2 weeks without treatment. Patients were reevaluated after 8 weeks of treatment; responding patients continued weekly docetaxel for a maximum of 32 weeks or until disease progression. RESULTS: Weekly docetaxel was well tolerated by this elderly group of patients with nonsmall cell lung carcinoma. Grade 3 leukopenia was noted in only 3 patients (8%), and no patient developed Grade 4 myelosuppression. Grade 3/4 nonhematologic toxicity also was uncommon; fatigue/asthenia was reported in 4 patients (10%). Seven of 38 evaluable patients (18%) had objective responses to weekly docetaxel whereas an additional 13 patients (34%) had a minor response or stable disease at first reevaluation. The median survival in this group of elderly patients was 5 months, with a 1-year actuarial survival rate of 27%. CONCLUSIONS: The results of the current study show that weekly docetaxel is active and well tolerated in elderly patients with advanced nonsmall cell lung carcinoma and provides an additional treatment option for these patients, who often tolerate combination chemotherapy regimens poorly.
Aged↗
Rituximab monoclonal antibody as initial systemic therapy for patients with low-grade non-Hodgkin lymphoma.
Rituximab, a chimeric antibody that targets CD20(+) B cells, produces a 48% response rate in patients with refractory low-grade non-Hodgkin lymphoma. In this phase II trial, patients with low-grade non-Hodgkin lymphoma who had previously received no systemic therapy were treated with rituximab, 375 mg/m(2), administered by IV infusion for 4 consecutive weeks. Patients with objective response or stable disease received repeat 4-week courses of rituximab at 6-month intervals. At the time of initial reevaluation at 6 weeks, 21 of 39 patients (54%) had objective response to treatment, and an additional 14 patients (36%) had stable disease or minor response. Response rates were similar in patients with follicular and small lymphocytic (CLL-type) lymphoma (52% versus 57%, respectively). At present, follow-up is short and only 13 patients have undergone a second course of rituximab treatment. However, 4 additional responses were documented either prior to the second course of rituximab (2 patients) or following the second course (2 patients) and 4 patients improved from partial to complete response. The current response rate is 64%, with 6 complete responses (15%). Treatment with rituximab was well tolerated, with only 1 patient experiencing grade 3/4 infusion-related toxicity. Rituximab is well tolerated and highly active in patients with low-grade non-Hodgkin lymphoma previously untreated with systemic therapy. Although further follow-up is required, the demonstration of minimal toxicity and considerable activity of this new biologic agent represents an important beginning of more specific, less toxic treatment for this important group of cancer patients.
Adult↗
Gemcitabine and vinorelbine in the second-line treatment of nonsmall cell lung carcinoma patients: a minnie pearl cancer research network phase II trial.
BACKGROUND: Second-line chemotherapy for patients with nonsmall cell lung carcinoma has been ineffective due to the lack of activity of older agents following platinum-based therapy. This Phase II trial evaluated the feasibility, toxicity, and efficacy of two active new agents, gemcitabine and vinorelbine, used in combination as second-line therapy for patients with nonsmall cell lung carcinoma. METHODS: Patients with advanced nonsmall cell lung carcinoma who had progressive disease after previous chemotherapy or combined-modality therapy were eligible for this trial. All patients received vinorelbine 20 mg/m(2) followed by gemcitabine 1000 mg/m(2) on Days 1, 8, and 15 of each 28-day cycle. Patients were reevaluated for a response after two treatment courses: responding patients and those with stable disease received a maximum of six courses. Fifty-five patients were treated between January 1998 and November 1998; 47 patients (85%) had previously received both a taxane and a platinum agent. RESULTS: Objective responses were seen in 9 of 50 evaluable patients (18%), including 8 partial responses and 1 complete response. Twenty-four additional patients (48%) had either minor response or stable disease. The median time to progression for patients with objective response or stable disease was 5 months. The median survival was 6.5 months with an actuarial 1-year survival of 20%. The treatment was well tolerated with uncommon nonhematologic toxicity and no alopecia. Grade 3 neutropenia and thrombocytopenia occurred in 27% and 22% of patients, respectively, but Grade 4 neutropenia was uncommon (occurring in 9% of patients) and only 4 patients required hospitalization for treatment of neutropenia and fever. CONCLUSIONS: The combination of vinorelbine and gemcitabine is active and well tolerated as second-line therapy for patients with advanced nonsmall cell lung carcinoma. This regimen merits further evaluation as a first-line therapy for patients with this disease.
Actuarial Analysis↗
Gemcitabine and paclitaxel combination therapy in transitional cell carcinoma of the urothelium.
Transitional cell carcinoma (TCC) of the urothelium is considered a chemosensitive malignancy; however, few patients receiving standard therapies achieve long-term disease control. Thus, new treatment approaches using more effective and less toxic agents are needed to improve prognosis in these patients. Two new agents currently being studied are gemcitabine and the taxanes; both of which have produced overall response rates ranging from 22.5 to 28% (gemcitabine), and 7-56% (paclitaxel) when used as single agents in this disease. Both agents have been well tolerated. Results of two phase II studies of gemcitabine combined with paclitaxel have been published. In one, 60% (15/25) of evaluable patients with advanced stage IV TCC responded; in the other, 53% (8/15) of patients with advanced and/or metastatic TCC responded. Several trials evaluating different dosing regimens of gemcitabine plus paclitaxel or docetaxel are ongoing or planned.
Adult↗