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Biomedical subjects

C P Belani

Publications and source records attributed to C P Belani.

At least 19 recordsLinked to original sources
PubMed2006

Randomized phase II trial of gemcitabine plus weekly versus three-weekly paclitaxel in previously untreated advanced non-small-cell lung cancer.

INTRODUCTION: Gemcitabine and paclitaxel (Taxol) each provides an efficacious non-platinum option for the treatment of advanced non-small-cell lung cancer (NSCLC), but the optimal dosage and schedule of the two agents used in combination are not well defined. METHODS: Previously untreated patients with advanced NSCLC were randomized to receive gemcitabine-paclitaxel on a traditional three-weekly schedule (Arm A) or a novel weekly schedule (Arm B) as follows-Arm A (three-weekly): gemcitabine 1000 mg/m2 infused>30 min on days 1 and 8 and paclitaxel 200 mg/m2 infused>3 h on day 1 of a 21-day cycle or Arm B (weekly): gemcitabine 1000 mg/m2 infused>30 min and paclitaxel 100 mg/m2 infused>1 h, both administered on days 1 and 8 of a 21-day cycle. RESULTS: One hundred patients received at least one dose of treatment. The weekly schedule, Arm B, was more efficacious and less hematologically toxic than Arm A. Confirmed complete and partial response rates were 28.2% and 26.8%, respectively. Median survival was 10.3 months on Arm B and 7.9 months on Arm A (log-rank P=0.10); 1- and 2-year survival rates also favor Arm B: 42.0% versus 34.0% and 18.0% versus 6.0%. Progression-free survival was 5.8 versus 4.8 months, again favoring Arm B (log-rank P=0.06). There was a two-fold lower frequency of grade 3/4 hematologic events with Arm B as follows: neutropenia (16% versus 30%), thrombocytopenia (4% versus 8%), and anemia (2% versus 6%). One patient (2%) in each treatment group developed febrile neutropenia. CONCLUSION: In this trial, both schedules were efficacious and tolerable, although the weekly schedule resulted in improved survival and lower hematologic toxicity compared with a three-weekly schedule. The weekly schedule of gemcitabine-paclitaxel indicates an improved therapeutic index.

Adenocarcinoma↗
PubMed2005

Randomized phase III trial comparing cisplatin-etoposide to carboplatin-paclitaxel in advanced or metastatic non-small cell lung cancer.

BACKGROUND: The present study was designed to evaluate the efficacy and safety of the regimen of carboplatin plus paclitaxel (investigational arm) versus the reference regimen of cisplatin plus etoposide for the treatment of advanced or metastatic non-small-cell lung cancer. PATIENTS AND METHODS: A total of 369 patients were enrolled, 179 on arm A (cisplatin 75 mg/m2 and etoposide 100 mg/m2) and 190 on arm B (carboplatin AUC=6 mg/ml min and paclitaxel 225 mg/m2), with cycles repeated every 3 weeks. The arms were well balanced with respect to age, performance status, weight loss, stage of disease and disease measurability. However, significantly more women were randomized to arm A than to arm B (P=0.039). RESULTS: The objective response rate (ORR) was 15% on arm A compared with 23% on arm B (P=0.061). Median survival time, time to progression and 1-year survival rates for arms A and B were 274 days and 233 days (P=0.086), 111 days and 121 days (P=0.877), and 37% and 32%, respectively. The most prevalent toxicities were neutropenia and leukopenia and they occurred at a higher rate in arm A than in arm B. CONCLUSION: There was no statistically significant survival advantage for carboplatin-paclitaxel compared with cisplatin-etoposide. However, there was an overall benefit in quality of life with the carboplatin-paclitaxel regimen.

Adult↗
PubMed2005

Skin rash and good performance status predict improved survival with gefitinib in patients with advanced non-small cell lung cancer.

BACKGROUND: Gefitinib (Iressa) is active as a single agent in the treatment of select patients with recurrent non-small cell lung cancer (NSCLC). The clinical characteristics of patients treated with gefitinib on an Expanded Access Program (EAP) at our institution identified predictive variables associated with better outcome. PATIENTS AND METHODS: Patients (n=199) with advanced NSCLC were treated with gefitinib (250 mg) upon progression with chemotherapy. Baseline patient characteristics were: median age, 69 years; males, 57%; adenocarcinoma, 56%. RESULTS: Partial responses were noted in two patients (1%) and disease stabilization in 66 (35%) patients. The median survival (MS) was 5.9 months [95% confidence interval (CI) 4.1-7.1] and median time to progression was 3 months (95% CI 2.0-3.0). The predictive factors analyzed were gender, skin rash, diarrhea, tumor histology and performance status (PS). Patients who developed skin rash (any grade) had MS of 10.8 months versus 4.0 months for those without rash (P <0.0001, log rank test). Patients with PS 0, 1 and 2 had MS of 8.4, 6.2 and 2.8 months, respectively (P <0.0002). The other factors did not impact survival. CONCLUSIONS: Occurrence of skin rash and baseline PS of 0/1 were associated with improved survival with gefitinib for recurrent NSCLC patients at our institution.

Adult↗
PubMed2004

Phase II study of topotecan and paclitaxel for patients with previously untreated extensive stage small-cell lung cancer.

BACKGROUND: This phase II study was conducted to evaluate the safety and efficacy of the combination of paclitaxel and topotecan for patients with extensive stage small-cell lung cancer (ED-SCLC). PATIENTS AND METHODS: Previously untreated ED-SCLC patients with Eastern Coperative Oncology Group performance status <2 were eligible. Treatment consisted of topotecan 1 mg/m2 (first three patients received 1.25 mg/m2), on days 1-5, and paclitaxel 135 mg/m2 over 24 h on day 5, every 4 weeks. Prophylactic granulocyte colony-stimulating factor was administered to all patients. RESULTS: Thirty-two patients received a median of four cycles of chemotherapy. Grade 4 anemia, neutropenia and thrombocytopenia occurred in 13, 31 and 18 patients, respectively. Thirty episodes of febrile neutropenia occurred in 22 patients. Grade 3 fatigue, esophagitis, stomatitis and hypotension occurred in one patient each. Of 26 patients eligible for response evaluation, there were six complete and 12 partial responses (overall response rate 69%). The median survival was 54 weeks. The 1-, 2- and 3-year survival rates were 50%, 10% and 3%, respectively. CONCLUSIONS: The combination of topotecan and paclitaxel is active as initial therapy in SCLC, but the efficacy is similar to 'standard therapy'. This combination was associated with a high incidence of myelosuppression and febrile neutropenia, at the doses evaluated.

Adult↗
PubMed2001

Outcome of patients with a performance status of 2 in Eastern Cooperative Oncology Group Study E1594: a Phase II trial in patients with metastatic nonsmall cell lung carcinoma .

BACKGROUND: Eastern Cooperative Oncology Group (ECOG) Study E1594 compared paclitaxel and cisplatin with three newer chemotherapy doublets in the treatment of patients with advanced nonsmall cell lung carcinoma (NSCLC). The accrual of patients with an ECOG performance status (PS) of 2 was discontinued due to a perceived rate of unacceptable toxicity. METHODS: Patients were stratified by PS and randomized to one of the following treatments: 1) paclitaxel (135 mg/m2) over 24 hours with cisplatin (75 mg/m2) on a 21-day cycle; 2) cisplatin (100 mg/m2) with gemcitabine (1 g/m2) on Days 1, 8, and 15 on a 28-day cycle; 3) cisplatin (75 mg/m2) with docetaxel (75 mg/m2) on a 21-day cycle; and 4) paclitaxel (225 mg/m2) over 3 hours with carboplatin (area under the curve, 6). All tests of statistical significance were two-sided. RESULTS: Sixty-eight patients with an ECOG PS of 2 were enrolled, and 64 patients were evaluable for toxicity and response. Fifty-six percent of 64 evaluable patients were male, and 81% had Stage IV disease. Grade 3-4 hematologic toxicities occurred in > 50% of the patients in each treatment group. Nonhematologic Grade 3-4 toxicities occurred significantly less often in the paclitaxel and carboplatin arm (P = 0.0032). The overall rate of toxicity did not differ significantly from the rate of toxicity in the PS-0 or PS-1 cohorts. There were 5 deaths (7.35%) among 68 patients with a PS of 2 during therapy; however, only 2 of those deaths were attributed to therapy. The overall response rate for the 64 evaluable patients was 14%. The overall median survival of all 68 patients with a PS of 2, as determined by an intent-to-treat analysis, was 4.1 months. CONCLUSIONS: Patients with advanced NSCLC and a PS of 2 experienced a large number of adverse reactions and overall poor survival. A comparison with patients with a PS of 0-1 suggests that these events and the shorter survival were related to disease process rather than treatment. Alternative strategies need to be explored with therapy specifically tailored for this group of patients.

Aged↗
PubMed2001

Interim analysis of a phase II study of induction weekly paclitaxel/carboplatin regimens followed by maintenance weekly paclitaxel for advanced and metastatic non-small cell lung cancer.

This multi-institutional randomized phase II study was designed to compare the efficacy and toxicity of three different weekly paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) and carboplatin schedules in patients with advanced and metastatic non-small cell lung cancer. The second part of the trial evaluated the role of maintenance weekly paclitaxel for those with response or stable disease after 16 weeks of initial treatment. Patients in arm 1 received paclitaxel 100 mg/m(2)/wk for 3 weeks along with carboplatin (area under the curve of 6) on day 1 every 4 weeks. The treatment in arm 2 was the same as in arm 1 except that carboplatin was also administered weekly (area under the curve of 2) for 3 weeks. Patients in arm 3 received paclitaxel 150 mg/m(2)/wk and carboplatin (area under the curve of 2 per week) during the second 8-week cycle. The total duration of this initial therapy was 16 weeks. All regimens were well tolerated. Arm 1 has the best therapeutic index and will exceed the median survival seen in previous phase III trials with traditional schedules of paclitaxel and carboplatin.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed2001

The role of positron emission tomography in evaluating mediastinal lymph node metastases in non-small-cell lung cancer.

Positron emission tomography (PET) is a modality that differentiates malignant from benign processes based upon metabolism rather than anatomy. A number of studies have confirmed improved accuracy of PET over computed tomography (CT), but until a few recent studies, most had failed to include satisfactory histologic confirmation. The objective of this study was to compare PET and CT to histologic staging of the mediastinum in patients with non-small-cell lung cancer (NSCLC). Histologic examination of mediastinal lymph nodes (MLNs) was performed on 40 patients with NSCLC at mediastinoscopy and/or at surgical resection. PET scans were interpreted by one of two nuclear medicine physicians, blinded to histology, using CT scans for anatomic localization. CT scans were independently evaluated for mediastinal lymphadenopathy. The overall accuracy, sensitivity, and specificity of PET were 78% (31 of 40), 67% (four of six), and 79% (27 of 34), respectively. The overall accuracy, sensitivity, and specificity of CT were 68% (27 of 40), 50% (three of six), and 71% (24 of 34), respectively. PET was superior to CT at correctly identifying mediastinal nodal metastases; however, both modalities were inferior to the gold standard of surgical staging. PET is more accurate than CT in staging the mediastinum of patients with NSCLC. PET failed to identify lymph node metastasis in 33% of patients with histologically proven MLN involvement, and false positives were present in 15%. At present, mediastinoscopy should remain the standard of care for preoperative mediastinal staging for NSCLC.

Journal Article↗
PubMed2001

Role of topoisomerase I inhibitors in small-cell lung cancer.

Lung cancer continues to be the leading cause of cancer-related death in the United States. Small-cell lung cancer constitutes 15%-20% of all cases of lung cancer. It is a chemosensitive disease with an overall response rate of 70%-90% in first-line treatment. However, the majority of patients relapse, and further treatment at that time is unlikely to achieve a durable response. Among the new drugs studied in this disease, topoisomerase I inhibitors are emerging as active agents with significant activity in both untreated and relapsed disease. This paper reviews the current status of irinotecan and topotecan in the treatment of small-cell lung cancer.

Journal Article↗
PubMed2000

Multicenter phase II trial of docetaxel and carboplatin in patients with stage IIIB and IV non-small-cell lung cancer.

PURPOSE: To evaluate the safety and efficacy of docetaxel and carboplatin as first-line therapy for patients with advanced non-small-cell lung cancer (NSCLC). PATIENTS AND METHODS: In this multicenter, phase II trial, 33 patients with previously untreated stage IIIB (n = 8) or IV (n = 25) NSCLC received intravenous infusions of docetaxel 80 mg/m2 followed immediately by carboplatin dosed to AUC of 6 mg/ml/min (Calvert's formula) every three weeks. Patients also received dexamethasone 8 mg orally twice daily for three days beginning one day before each docetaxel treatment. Filgrastim was not allowed during the first cycle and was added only if a patient experienced febrile neutropenia or grade 4 neutropenia lasting > or = 7 days. RESULTS: There were 1 complete and 11 partial responses for an objective response rate of 43% (95% CI: 24%-63%) in 28 evaluable patients and 36% (95% CI: 20%-55%) in the intent-to-treat population. The median duration of response was 5.5 months (range 3.0-12.5 months). The median survival was 13.9 months (range 1-35+ months); one-year survival was 52%. The most common toxicity was hematologic, which included grade 4 neutropenia (79% of patients and 7% percent of cycles) and febrile neutropenia (15% of patients); there were no episodes of grade 3 or 4 infection. The most common severe nonhematologic toxicities were asthenia (24%) and myalgia (12%); there were no grade 3 or 4 neurologic effects. CONCLUSIONS: The combination of docetaxel and carboplatin has an acceptable toxicity profile and is active in the treatment of previously untreated patients with advanced NSCLC. This combination is being evaluated in a randomized phase III trial involving patients with advanced and metastatic NSCLC.

Aged↗
PubMed2000

Combined modality therapy for unresectable stage III non-small cell lung cancer: new chemotherapy combinations.

Over the last decade, we have witnessed improved outcome among patients with non-small cell lung cancer (NSCLC), principally through the use of new and novel treatment programs. A meta-analysis of randomized clinical trials comparing combined chemotherapy and radiation to radiation therapy alone clearly has shown a survival benefit with platinum-based combination chemotherapy administered sequentially or concurrently with thoracic radiation therapy over radiation therapy alone. In addition, combining thoracic radiation therapy with novel drugs or new drug combinations has yielded improvements in median survival duration and long-term survival rates in locally advanced unresectable NSCLC. Paclitaxel and carboplatin are two novel agents that have undergone extensive clinical evaluation at various doses and schedules in combination with thoracic radiation therapy in patients with locally advanced disease. There remains a need, however, for further improvement in metastatic control and prevention of locoregional recurrences. This will likely be achieved through the optimization of chemotherapy regimens to be used in combined modality therapy with thoracic radiation therapy.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed2000

Paclitaxel and docetaxel combinations in non-small cell lung cancer.

Paclitaxel, the first of the taxanes, has exhibited unique and encouraging single-agent activity in the treatment of non-small cell lung cancer (NSCLC). Yet, with single-agent response rates approaching 25%, it was logical to examine the impact of paclitaxel in combination chemotherapy regimens. In trials evaluating the activity of paclitaxel in combination with one of the platinum compounds, cisplatin or carboplatin, response rates have ranged from 35 to > 50% and were significantly better than response rates observed with etoposide/cisplatin, the previous standard regimen for treatment of NSCLC. Docetaxel is a newer taxane that also has exhibited notable single-agent activity and response rates ranging from 20 to 50% when combined with cisplatin. Future research will look to refine the use of taxane combinations in NSCLC and to examine the potential of these unique and promising drugs when combined with newer agents that are active against this disease.

Antineoplastic Agents, Phytogenic↗
PubMed2000

Total videothoracoscopic lobectomy versus open thoracotomy for early-stage non small-cell lung cancer.

Lobectomy remains the standard procedure for early-stage non small-cell lung cancer (NSCLC). Advances in minimally invasive surgery allow lobectomy to be performed by videothoracoscopy (VATSLOBE). The objective of this study was to compare open thoracotomy (OPENLOBE) to VATSLOBE in the treatment of early-stage NSCLC. A retrospective review over a 6-year period at a single tertiary care center identified 31 patients treated by VATSLOBE. A comparison was made with 31 patients undergoing OPENLOBE during the same time period. The cases were matched for age, pulmonary function testing, tumor size, and comorbidities. The VATSLOBE technique was carried out using four 1 cm thoracoports, one of which was enlarged to a 4-6 cm access incision for lobe retrieval. OPENLOBE was performed by standard posterolateral thoracotomy. The VATSLOBE group had a longer operative time (214.03 min) compared to OPENLOBE (140.67 min). There was no difference in the extent of lymph node dissection or in morbidity between the two groups. VATSLOBE patients had their chest tubes removed earlier (4.77 vs. 8.16 days) and stayed in the hospital for a shorter time (7.07 vs. 11.94 days) compared to OPENLOBE patients. In this retrospective review, lobectomy performed by the videothoracoscopic approach was comparable to OPENLOBE in terms of lymph node dissection, morbidity, and long-term survival. VATSLOBE had the advantages of a shorter hospital stay and fewer days with a chest tube. Minimally invasive surgery for early-stage lung cancer should be further investigated in multi-institutional controlled trials.

Journal Article↗