16 results on '"Jett, James R."'
Search Results
2. Phase 2 trial of pemetrexed disodium and carboplatin in previously untreated extensive-stage small cell lung cancer, N0423.
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Chee CE, Jett JR, Bernath AM Jr, Foster NR, Nelson GD, Molina J, Nikcevich DA, Steen PD, Flynn PJ, and Rowland KM Jr
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- Age Factors, Aged, Antineoplastic Combined Chemotherapy Protocols adverse effects, Disease-Free Survival, Female, Guanine administration & dosage, Humans, Lung Neoplasms mortality, Lung Neoplasms pathology, Male, Middle Aged, Pemetrexed, Small Cell Lung Carcinoma mortality, Small Cell Lung Carcinoma pathology, Treatment Outcome, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Carboplatin administration & dosage, Glutamates administration & dosage, Guanine analogs & derivatives, Lung Neoplasms drug therapy, Small Cell Lung Carcinoma drug therapy
- Abstract
Background: In extensive-stage small cell lung cancer (SCLC), the combination of pemetrexed plus carboplatin has shown activity and appeared to be well-tolerated. We conducted a trial to confirm the efficacy and to assess the tolerability of this chemotherapy combination., Methods: Patients with untreated extensive-stage SCLC were enrolled in this phase 2 open-labeled study. They receive pemetrexed 500 mg/m(2) and carboplatin (area under the curve of 5) every 21 days for a maximum 6 cycles. The primary endpoint for this trial was the confirmed response rate and the accrual goal was 70 patients., Results: Forty-six eligible patients (29 aged <70 years, 17 aged >or=70 years) were accrued to this study. The efficacy outcomes were similar between the 2 age groups. Overall, the confirmed response rate was 35% (16 of 46; 95% confidence interval [CI], 21%-50%), where all 16 were partial responses. On the basis of these results, we had strong evidence that the study would not meet the preset efficacy criteria and was, therefore, closed before full accrual. The median duration of response was 4.4 months (95% CI, 2.9-5.2). Median overall survival for patients aged <70 years and aged >or=70 years was 9.2 months (95% CI, 5.4-11.6) and 10.8 months (95% CI, 2.2-14.3), respectively. Grade 3 or higher toxicity rates were similar between the younger and older patients. Grade 3/4 and grade 4 hematological toxicities were observed in 46% and 26% of patients, respectively., Conclusions: Although well-tolerated, the combination of pemetrexed and carboplatin is not as effective as standard therapy in patients with untreated extensive-stage SCLC., ((c) 2010 American Cancer Society.)
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- 2010
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3. Treatment of non-small cell lung cancer, stage IIIB: ACCP evidence-based clinical practice guidelines (2nd edition).
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Jett JR, Schild SE, Keith RL, and Kesler KA
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- Aged, Angiogenesis Inhibitors administration & dosage, Antibodies, Monoclonal administration & dosage, Antibodies, Monoclonal, Humanized, Antineoplastic Agents administration & dosage, Bevacizumab, Carboplatin administration & dosage, Carcinoma, Non-Small-Cell Lung pathology, Cytotoxins administration & dosage, Evidence-Based Medicine, Humans, Lung Neoplasms pathology, Neoplasm Staging, Paclitaxel administration & dosage, Platinum administration & dosage, Quality of Life, Treatment Outcome, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Carcinoma, Non-Small-Cell Lung drug therapy, Lung Neoplasms therapy
- Abstract
Objective: To develop evidence-based guidelines on best available treatment options for patients with stage IIIB non-small cell lung cancer (NSCLC)., Methods: A review was conducted of published English-language (abstract or full text) phase II or phase III trials and guidelines from other organizations that address management of the various categories of stage IIIB disease. The literature search was provided by the Duke University Center for Clinical Health Policy Research and supplemented by any additional studies known by the authors., Results: Surgery may be indicated for carefully selected patients with T4N0-1M0. Patients with N3 nodal involvement are not considered to be surgical candidates. For individuals with unresectable disease, good performance score, and minimal weight loss, treatment with combined chemoradiotherapy results in better survival than radiotherapy (RT) alone. Concurrent chemoradiotherapy seems to be associated with improved survival compared with sequential chemoradiotherapy. Multiple daily fractions of RT when combined with chemotherapy have not been shown to result in improved survival compared with standard once-daily RT combined with chemotherapy. The optimal chemotherapy agents and the number of cycles of treatment to combine with RT are uncertain., Conclusion: Prospective trials are needed to answer important questions, such as the role of induction therapy in patients with potentially resectable stage IIIB disease. Future trials are needed to answer the questions of optimal chemotherapy agents and radiation fractionation schedule. The role of targeted novel agents in combination with chemoradiotherapy is just starting to be investigated.
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- 2007
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4. Phase I trial of sorafenib in combination with gefitinib in patients with refractory or recurrent non-small cell lung cancer.
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Adjei AA, Molina JR, Mandrekar SJ, Marks R, Reid JR, Croghan G, Hanson LJ, Jett JR, Xia C, Lathia C, and Simantov R
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- Aged, Antineoplastic Combined Chemotherapy Protocols adverse effects, Benzenesulfonates adverse effects, Dose-Response Relationship, Drug, Female, Gefitinib, Humans, Male, Middle Aged, Niacinamide analogs & derivatives, Phenylurea Compounds, Pyridines adverse effects, Quinazolines adverse effects, Sorafenib, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Benzenesulfonates therapeutic use, Carcinoma, Non-Small-Cell Lung drug therapy, Lung Neoplasms drug therapy, Neoplasm Recurrence, Local drug therapy, Pyridines therapeutic use, Quinazolines therapeutic use
- Abstract
Purpose: To evaluate the combination of sorafenib and gefitinib in patients with advanced non-small cell lung cancer., Experimental Design: In this dose-escalation trial, patients received oral sorafenib (200-400 mg) twice daily with gefitinib (250 mg orally) once daily to identify the recommended dose for phase II trials (RDP; part A). The pharmacokinetics of the RDP were characterized further in additional patients (part B) receiving single-agent gefitinib or sorafenib for 21 days followed by a 7-day washout with crossover to the other agent for an additional 21 days. Patients then received the combination of sorafenib plus gefitinib in 28-day cycles. Safety, pharmacokinetics, and antitumor efficacy were evaluated. Potential drug-drug interactions and the relationship between pharmacokinetics and toxicity were also assessed., Results: Thirty-one patients were treated (n=12, part A; n=19, part B). Most adverse events were grade 1/2. The most frequent grade 3/4 events included diarrhea and elevated alanine aminotransferase (both 9.7%). One dose-limiting toxicity occurred (part A: elevated alanine aminotransferase at 400 mg twice daily). Gefitinib had no effect on sorafenib pharmacokinetics. However, gefitinib C(max) (26%) and area under the curve (38%) were reduced by concomitant sorafenib. One patient had a partial response; 20 (65%; n=8, part A; n=12, part B) had stable disease >or=4 months. The RDP was sorafenib 400 mg twice daily with gefitinib 250 mg once daily., Conclusions: Sorafenib combined with gefitinib is well tolerated, with promising efficacy in patients with advanced non-small cell lung cancer. Studies to further investigate the significance of the reduction in gefitinib exposure by sorafenib are warranted.
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- 2007
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5. Phase I North Central Cancer Treatment Group Trial-N9923 of escalating doses of twice-daily thoracic radiation therapy with amifostine and with alternating chemotherapy in limited stage small-cell lung cancer.
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Garces YI, Okuno SH, Schild SE, Mandrekar SJ, Bot BM, Martens JM, Wender DB, Soori GS, Moore DF Jr, Kozelsky TF, and Jett JR
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- Adult, Aged, Amifostine administration & dosage, Cisplatin administration & dosage, Combined Modality Therapy methods, Cranial Irradiation, Etoposide administration & dosage, Female, Humans, Male, Middle Aged, Paclitaxel administration & dosage, Quality Control, Quality of Life, Radiotherapy Dosage, Topotecan administration & dosage, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Carcinoma, Small Cell drug therapy, Carcinoma, Small Cell radiotherapy, Lung Neoplasms drug therapy, Lung Neoplasms radiotherapy, Radiation-Sensitizing Agents therapeutic use
- Abstract
Purpose: The primary goal was to identify the maximum tolerable dose (MTD) of thoracic radiation therapy (TRT) that can be given with chemotherapy and amifostine for patients with limited-stage small-cell lung cancer (LSCLC)., Methods and Materials: Treatment began with two cycles of topotecan (1 mg/m(2)) Days 1 to 5 and paclitaxel (175 mg/m(2)) Day 5 (every 3 weeks) given before and after TRT. The TRT began at 6 weeks. The TRT was given in 120 cGy fractions b.i.d. and the dose escalation (from 4,800 cGy, dose level 1, to 6,600 cGy, dose level 4) followed the standard "cohorts of 3" design. The etoposide (E) (50 mg/day) and cisplatin (C) (3 mg/m(2)) were given i.v. before the morning TRT and amifostine (500 mg/day) was given before the afternoon RT. This was followed by prophylactic cranial irradiation (PCI). The dose-limiting toxicities (DLTs) were defined as Grade > or =4 hematologic, febrile neutropenia, esophagitis, or other nonhematologic toxicity, Grade > or =3 dyspnea, or Grade > or =2 pneumonitis., Results: Fifteen patients were evaluable for the Phase I portion of the trial. No DLTs were seen at dose levels 1 and 2. Two patients on dose level 4 experienced DLTs: 1 patient had a Grade 4 pneumonitis, dyspnea, fatigue, hypokalemia, and anorexia, and 1 patient had a Grade 5 hypoxia attributable to TRT. One of 6 patients on dose level 3 had a DLT, Grade 3 esophagitis. The Grade > or =3 toxicities seen in at least 10% of patients during TRT were esophagitis (53%), leukopenia (33%), dehydration (20%), neutropenia (13%), and fatigue (13%). The median survival was 14.5 months., Conclusion: The MTD of b.i.d. TRT was 6000 cGy (120 cGy b.i.d.) with EP and amifostine.
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- 2007
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6. Impact of pretreatment factors on adverse events: a pooled analysis of North Central Cancer Treatment Group advanced stage non-small cell lung cancer trials.
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Mandrekar SJ, Northfelt DW, Schild SE, Foster NR, Bot B, Marks RS, Mailliard JA, Krook JE, Maksymiuk AW, Adjei AA, and Jett JR
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- Adult, Age Factors, Aged, Aged, 80 and over, Analysis of Variance, Antineoplastic Combined Chemotherapy Protocols administration & dosage, Carcinoma, Non-Small-Cell Lung mortality, Clinical Trials as Topic, Comorbidity, Female, Humans, Logistic Models, Lung Neoplasms mortality, Male, Manitoba, Maximum Tolerated Dose, Middle Aged, Multivariate Analysis, Neoplasm Staging, Predictive Value of Tests, Prognosis, Registries, Risk Assessment, Sex Factors, Survival Analysis, Antineoplastic Combined Chemotherapy Protocols adverse effects, Carcinoma, Non-Small-Cell Lung drug therapy, Carcinoma, Non-Small-Cell Lung pathology, Drug-Related Side Effects and Adverse Reactions epidemiology, Lung Neoplasms drug therapy, Lung Neoplasms pathology
- Abstract
Introduction: This pooled analysis was performed to examine the impact of pretreatment factors on severe (grade 3 or higher) adverse events (AE) in patients with advanced stage non-small cell lung cancer (NSCLC)., Methods: A pooled data set of 1053 participants from nine North Central Cancer Treatment Group clinical trials was used. Age, gender, performance status, tumor stage, body mass index, serum creatinine levels, hemoglobin levels, white blood cell counts, and platelet counts were evaluated univariately and multivariately using logistic regression. The magnitude of the effects of the pretreatment factors after adjusting for type of chemotherapy agent (platinum versus no platinum) was explored in the final multivariate model., Results: Women and older participants had a significantly greater risk for experiencing severe hematologic and non-hematologic AE. Participants with performance status >0 had an increased risk for severe non-hematologic AE. For every one unit (10/L) increase in pretreatment white blood cell count, there was an 11% reduction in the odds of experiencing a severe hematologic AE. The magnitude of these effects on the end points remained similar after adjusting for type of chemotherapy agent., Conclusions: Pretreatment factors of gender, age, performance status, and hematologic parameters were significant predictors of severe AE among patients with advanced stage NSCLC. This suggests the need to control or adjust for factors that predispose patients to an increased risk of severe AE. These findings can aid in tailoring therapy to individual patients and in the proper design of future clinical trials.
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- 2006
7. Phase II NCCTG trial of oral topotecan and paclitaxel with G-CSF (filgrastim) support in patients with previously untreated extensive-stage small cell lung cancer.
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Molina JR, Jett JR, Foster N, Lair BS, Carroll TJ, Tazelaar HD, Hillman S, Mailliard JA, Bernath AM Jr, and Nikcevich D
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- Administration, Oral, Adult, Aged, Aged, 80 and over, Antineoplastic Combined Chemotherapy Protocols adverse effects, Disease Progression, Female, Granulocyte Colony-Stimulating Factor administration & dosage, Humans, Infusions, Intravenous, Injections, Subcutaneous, Male, Middle Aged, Paclitaxel administration & dosage, Survival Analysis, Topotecan administration & dosage, Treatment Outcome, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Carcinoma, Small Cell drug therapy, Lung Neoplasms drug therapy
- Abstract
Objective: To determine the efficacy and toxicity of oral topotecan and paclitaxel in untreated patients with extensive stage small cell lung cancer (SCLC)., Patients and Methods: Thirty-eight patients received 1.75 mg/m2 of oral topotecan days 1 to 5 and 175 mg/m2 paclitaxel IV over 3 hours on day 5 (after topotecan) every 4 weeks for 6 cycles. Subcutaneous G-CSF at a dose of 5 microg/kg was then given 24 to 48 hours after the last dose of chemotherapy and daily for 10 days., Results: All 38 patients were available for toxicity and response analysis. A median of 5 treatment cycles was given, with a range of 1 to 7 cycles. Seventeen (45%) patients received at least 6 cycles of treatment. The most common severe adverse events were neutropenia (42.1%), leukopenia (34.2%), thrombocytopenia (18.4%), nausea (18.4%), diarrhea (13.2%), and fatigue (13.2%). Two grade 5 treatment-related evens were seen. The median overall survival was 9.1 month (95% CI: 7.5-13.0 months), with a 1-year survival estimate of 44.7% (95% CI: 31.4-63.7%) and a 2-year survival rate of 5.3% (95% CI: 1.4-20.3%). The median time to progression was 5.0 months (95% CI: 3.8-6.6 months), with a 1-year progression-free rate of 5.8% (95% CI: 1.5-22.2%) and a 2-year progression-free rate of 2.9% (95% CI: 0.4-19.9%). The estimated confirmed response rate was 52.9%., Conclusion: This regimen has shown similar antitumor activity to that achieved with standard therapy. Because of unacceptable toxicity and cost, we do not recommend this regimen in a palliative setting.
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- 2006
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8. Topotecan and paclitaxel in previously treated patients with relapsed small cell lung cancer: phase II trial of the North Central Cancer Treatment Group.
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Dy GK, Jett JR, Geoffroy FJ, Krewer KD, Tazelaar H, Maurer M, Rowland K, Mailliard J, Krook J, Dakhil S, Kutteh L, Kugler J, and Wender D
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- Adult, Aged, Antineoplastic Combined Chemotherapy Protocols adverse effects, Brain Neoplasms secondary, Carcinoma, Small Cell mortality, Disease Progression, Female, Humans, Kaplan-Meier Estimate, Lung Neoplasms mortality, Male, Middle Aged, Neutropenia chemically induced, Paclitaxel adverse effects, Survival Rate, Topotecan adverse effects, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Carcinoma, Small Cell drug therapy, Lung Neoplasms drug therapy, Neoplasm Recurrence, Local drug therapy, Paclitaxel administration & dosage, Topotecan administration & dosage
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- 2006
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9. Randomized phase II trial of three schedules of pemetrexed and gemcitabine as front-line therapy for advanced non-small-cell lung cancer.
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Ma CX, Nair S, Thomas S, Mandrekar SJ, Nikcevich DA, Rowland KM, Fitch TR, Windschitl HE, Hillman SL, Schild SE, Jett JR, Obasaju C, and Adjei AA
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- Adult, Aged, Aged, 80 and over, Carcinoma, Non-Small-Cell Lung pathology, Deoxycytidine administration & dosage, Deoxycytidine analogs & derivatives, Disease Progression, Drug Administration Schedule, Female, Glutamates administration & dosage, Guanine administration & dosage, Guanine analogs & derivatives, Humans, Infusions, Intravenous, Lung Neoplasms pathology, Male, Middle Aged, Pemetrexed, Survival Analysis, Treatment Outcome, Gemcitabine, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Carcinoma, Non-Small-Cell Lung drug therapy, Lung Neoplasms drug therapy
- Abstract
Purpose: A randomized three-arm phase II study was undertaken to evaluate the optimum administration schedule of pemetrexed and gemcitabine in chemotherapy-naïve patients with non-small-cell lung cancer., Patients and Methods: Patients were randomly assigned to three schedules of pemetrexed 500 mg/m2 plus gemcitabine 1,250 mg/m2, separated by a 90-minute interval, on a 21-day cycle as follows: schedule A, pemetrexed followed by gemcitabine on day 1 and gemcitabine on day 8; schedule B, gemcitabine followed by pemetrexed on day 1 and gemcitabine on day 8; and schedule C, gemcitabine on day 1 and pemetrexed followed by gemcitabine on day 8., Results: One hundred fifty-two eligible patients (schedule A, n = 59; schedule B, n = 31, and schedule C, n = 62) received a median of five (schedule A), two (schedule B), and four (schedule C) treatment cycles. Overall, 66% of patients experienced grade 3 or 4 neutropenia. Common grade 3 and 4 nonhematologic toxicities were dyspnea (11%), fatigue (16%), and transaminase elevation (9%). Schedule A seemed less toxic compared with schedule C (grade 3 or 4 events: 86% v 94%, respectively; P = .19; grade 4 events: 39% v 48%, respectively; P = .30). Schedule B was closed at interim analysis for inferior efficacy. Schedule A, with a confirmed response rate of 31% (95% CI, 20% to 45%), met the protocol-defined efficacy criteria, whereas schedule C, with a confirmed response rate of 16.1% (95% CI, 11% to 34%), did not. Median survival time and time to progression were 11.4 and 4.4 months, respectively, with no observable difference between the arms., Conclusion: Pemetrexed and gemcitabine administered as outlined for schedule A met the protocol-defined efficacy criteria, was less toxic compared with the other treatment schedules, and should be further evaluated.
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- 2005
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10. Results of combined-modality therapy for limited-stage small cell lung carcinoma in the elderly.
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Schild SE, Stella PJ, Brooks BJ, Mandrekar S, Bonner JA, McGinnis WL, Mailliard JA, Krook JE, Deming RL, Adjei AA, Jatoi A, and Jett JR
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- Adult, Age Distribution, Aged, Aged, 80 and over, Cisplatin administration & dosage, Combined Modality Therapy, Drug Administration Schedule, Etoposide administration & dosage, Female, Humans, Male, Middle Aged, Radiotherapy Dosage, Survival Rate, Treatment Outcome, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Carcinoma, Small Cell drug therapy, Carcinoma, Small Cell radiotherapy, Lung Neoplasms drug therapy, Lung Neoplasms radiotherapy
- Abstract
Background: A Phase III trial was conducted by the North Central Cancer Treatment Group to determine whether chemotherapy (etoposide and cisplatin) plus either twice-daily radiotherapy (BIDRT) or once-daily radiotherapy (QDRT) resulted in a better outcome for patients with limited-stage small cell lung carcinoma (LD-SCLC). No difference in survival was identified between the two arms. The current analysis examined the relation between age and outcome for patients treated during this trial., Methods: The current study included 263 patients with LD-SCLC and an Eastern Cooperative Oncology Group performance status of < or = 2 who were randomized to receive QDRT or split-course BIDRT. The outcomes of the 209 (79%) younger patients (age < 70 years old) were compared with the 54 (21%) elderly patients (age > or = 70 years old)., Results: Elderly patients presented with significantly greater weight loss and poorer performance status. The 2-year and 5-year survival rates were 48% and 22% for younger patients compared with 33% and 17% for older patients (P = 0.14). One specific toxicity (i.e., Grade > or = 4 pneumonitis [according to National Cancer Institute Common Toxicity Criteria]) occurred in 0% of those patients age < 70 years compared with 6% of older patients (P = 0.008). Grade 5 toxicity occurred in 1 of 209 (0.5%) patients age < 70 years compared with 3 of 54 (5.6%) older patients (P = 0.03)., Conclusions: Despite having more weight loss, poorer performance status, increased pulmonary toxicity, and more deaths due to treatment, survival was not found to be significantly worse in older individuals. Fit elderly patients with LD-SCLC can receive combined-modality therapy with the expectation of relatively favorable long-term survival. Future research should focus on ways to decrease toxicity especially in the elderly.
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- 2005
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11. Long-term results of a phase III trial comparing once-daily radiotherapy with twice-daily radiotherapy in limited-stage small-cell lung cancer.
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Schild SE, Bonner JA, Shanahan TG, Brooks BJ, Marks RS, Geyer SM, Hillman SL, Farr GH Jr, Tazelaar HD, Krook JE, Geoffroy FJ, Salim M, Arusell RM, Mailliard JA, Schaefer PL, and Jett JR
- Subjects
- Adult, Aged, Aged, 80 and over, Cisplatin administration & dosage, Combined Modality Therapy, Cranial Irradiation, Dose Fractionation, Radiation, Etoposide administration & dosage, Female, Humans, Male, Middle Aged, Radiotherapy adverse effects, Survival Analysis, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Carcinoma, Small Cell drug therapy, Carcinoma, Small Cell radiotherapy, Lung Neoplasms drug therapy, Lung Neoplasms radiotherapy
- Abstract
Purpose: This Phase III study was performed to determine whether twice-daily (b.i.d.) radiotherapy (RT) resulted in better survival than once-daily (q.d.) RT for patients with limited-stage small-cell lung cancer (LD-SCLC)., Methods and Materials: A total of 310 patients with LD-SCLC initially received three cycles of etoposide and cisplatin. Subsequently, the 261 patients without significant progression were randomized to two cycles of etoposide and cisplatin plus either q.d. RT (50.4 Gy in 28 fractions) or split-course b.i.d. RT (24 Gy in 16 fractions, a 2.5-week break, and 24 Gy in 16 fractions) to the chest. Patients then received a sixth cycle of etoposide and cisplatin followed by prophylactic cranial RT., Results: Follow-up ranged from 4.6 to 11.9 years (median, 7.4 years). The median survival and 5-year survival rate from randomization was 20.6 months and 21% for patients who received q.d. RT compared with 20.6 months and 22% for those who received b.i.d. RT (p = 0.68), respectively. No statistically significant differences were found in the rates of progression (p = 0.68), intrathoracic failure (p = 0.45), in-field failure (p = 0.62), or distant failure (p = 0.82) between the two treatment arms. No statistically significant difference was found in the overall rate of Grade 3 or worse (p = 0.83) or Grade 4 or worse toxicity (p = 0.95). Grade 3 or worse esophagitis (p = 0.05) was more common in the b.i.d. arm. Grade 5 toxicity occurred in 4 (3%) of 130 patients who received b.i.d. RT compared with 0 (0%) of 131 who received q.d. RT (p = 0.04)., Conclusion: Although this study did not demonstrate an advantage to split-course b.i.d. RT, the long-term survival was favorable, likely reflecting the positive influences of concurrent combined modality therapy and prophylactic cranial RT.
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- 2004
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12. Weekly carboplatin and paclitaxel in elderly non-small-cell lung cancer patients (>or=65 years of age): a phase II North Central Cancer Treatment Group study.
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Jatoi A, Stella PJ, Hillman S, Mailliard JA, Vanone S, Perez EA, Cannon MW, Geyer S, Wiesenfeld M, and Jett JR
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- Aged, Aged, 80 and over, Humans, Survival Analysis, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Carboplatin administration & dosage, Carcinoma, Non-Small-Cell Lung drug therapy, Lung Neoplasms drug therapy, Paclitaxel administration & dosage
- Abstract
The purpose of this study was to determine the tumor response rate and toxicity profile of low-dose weekly carboplatin and paclitaxel in advanced non-small-cell lung cancer (SCLC) patients 65 or more years of age. Forty-nine patients 65 years of age or more with advanced non-SCLC with a median age of 73 years (range: 65-85) and an Eastern Cooperative Oncology Group performance status of 0, 1, or 2 in 31%, 47%, and 22% of patients, respectively, were treated and evaluated. Patients received carboplatin (AUC = 2) and paclitaxel 50 mg/m2 on days 1, 8, and 15 of a 4-week cycle. The overall confirmed tumor response rate was 14% (95% CI: 4.7%, 32.5%) with no complete responses. The 1-year survival rate was 31% (95% CI: 20%, 48%). There was one treatment-related death, and there were two grade IV allergic reactions to chemotherapy. No other grade IV or V treatment-related toxicities were observed. There were only three episodes of grade III myelosuppression. Low-dose weekly carboplatin and paclitaxel, as prescribed in this trial, provides modest activity in the treatment of advanced non-SCLC patients 65 or more years of age. However, the relatively mild toxicity profile observed in this trial suggests that this regimen might remain an option for patients at increased risk for myelosuppression or with a poor performance status.
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- 2003
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13. The outcome of combined-modality therapy for stage III non-small-cell lung cancer in the elderly.
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Schild SE, Stella PJ, Geyer SM, Bonner JA, McGinnis WL, Mailliard JA, Brindle J, Jatoi A, and Jett JR
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- Adult, Age Factors, Aged, Aged, 80 and over, Chi-Square Distribution, Cisplatin administration & dosage, Combined Modality Therapy, Disease Progression, Etoposide administration & dosage, Female, Humans, Male, Middle Aged, Radiotherapy Dosage, Retrospective Studies, Survival Analysis, Treatment Outcome, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Carcinoma, Non-Small-Cell Lung drug therapy, Carcinoma, Non-Small-Cell Lung radiotherapy, Lung Neoplasms drug therapy, Lung Neoplasms radiotherapy
- Abstract
Purpose: The North Central Cancer Treatment Group performed a phase III trial to determine whether chemotherapy plus either bid radiation therapy (RT) or daily (qd) RT resulted in a better outcome for patients with stage III non-small-cell lung cancer (NSCLC). No difference in survival was identified between the two arms. This secondary analysis was performed to examine the relationship between patient age and outcome., Patients and Methods: Two hundred forty-six patients were randomized to receive etoposide plus cisplatin and either RT qd or split-course RT bid. This retrospective study compared the outcomes of patients aged >/=70 years ("elderly patients") with those of younger individuals. Of the 244 assessable patients, 63 (26%) were elderly, and 181 (74%) were younger individuals., Results: The 2-year and 5-year survival rates were 39% and 18%, respectively, in patients younger than 70 years, compared with 36% and 13%, respectively, in elderly patients (P =.4). Grade 4+ toxicity occurred in 62% of patients younger than 70 years compared with 81% of elderly patients (P =.007). Grade 4+ hematologic toxicity occurred in 56% of patients younger than 70 years, compared with 78% of elderly patients (P =.003). Grade 4+ pneumonitis occurred in 1% of those younger than 70 years, compared with 6% of elderly patients (P =.02)., Conclusion: Toxicity, especially myelosuppression and pneumonitis, was more pronounced in the elderly patients receiving combined-modality therapy for locally advanced NSCLC. Despite increased toxicity, elderly patients have survival rates equivalent to younger individuals. Therefore, fit, elderly patients with locally advanced NSCLC should be encouraged to receive combined-modality therapy, preferably on clinical trials with cautious, judicious monitoring. Future studies should explore ways to decrease toxicity of therapy in elderly patients.
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- 2003
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14. Alternating chemotherapy with etoposide plus cisplatin and topotecan plus paclitaxel in patients with untreated, extensive-stage small cell lung carcinoma: a phase II trial of the North Central Cancer Treatment Group.
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Jett JR, Hatfield AK, Hillman S, Bauman MD, Mailliard JA, Kugler JW, Morton RF, Marks RS, and Levitt R
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- Adult, Aged, Aged, 80 and over, Antineoplastic Combined Chemotherapy Protocols adverse effects, Carcinoma, Small Cell mortality, Carcinoma, Small Cell pathology, Cisplatin administration & dosage, Drug Administration Schedule, Etoposide administration & dosage, Female, Humans, Illinois, Indiana, Iowa, Lung Neoplasms mortality, Lung Neoplasms pathology, Male, Middle Aged, Minnesota, Nebraska, Neoplasm Staging, North Dakota, Paclitaxel administration & dosage, South Dakota, Survival Analysis, Topotecan administration & dosage, Treatment Outcome, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Carcinoma, Small Cell drug therapy, Lung Neoplasms drug therapy
- Abstract
Background: The objective of this study was to test the response rate and toxicity of alternating chemotherapy in previously untreated patients with extensive-stage small cell lung carcinoma (SCLC)., Methods: Patients with histologically proven, extensive-stage SCLC, with a performance status of 0-2, and who had received no prior chemotherapy were eligible. The design was a two-stage, Phase II, multicenter trial. Treatment consisted of alternating chemotherapy every 3 weeks with etoposide (100 mg/m(2) on Days 1-3) and cisplatin (30 mg/m(2) on Days 1-3) on Cycles 1, 3, 5 and with topotecan (1 mg/m(2) on Days 1-5) and paclitaxel (200 mg/m(2) on Day 5) on Cycles 2, 4, and 6. Filgrastim support was given with Cycles 2, 4, 6., Results: Forty-four patients were eligible and evaluable. The primary toxicity was myelosuppression. The median absolute neutrophil count was 300/microL with 70% Grade 4 neutropenia. The median platelet count was 58,000/microL with 23% Grade 4 thrombocytopenia. Grade 4 nonhematologic toxicities occurred in 16% of patients. Overall toxicities were not different between the two regimens. There were no treatment-related deaths. Complete or partial responses occurred in 34 patients (77%). The median time to progression was 6.9 months, with a median survival of 10.5 months and with 1-year and 2-year survival rates of 37% and 12%, respectively., Conclusions: The regimen of alternating chemotherapy was associated with substantial myelosuppression and resulted in a high response rate and good overall survival. The results were similar to those reported in prior trials and did not suggest any improvement in therapy for patients with SCLC., (Copyright 2003 American Cancer Society.DOI 10.1002/cncr.11377)
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- 2003
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15. Phase III trial comparing chemotherapy plus once-daily or twice-daily radiotherapy in Stage III non-small-cell lung cancer.
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Schild SE, Stella PJ, Geyer SM, Bonner JA, Marks RS, McGinnis WL, Goetz SP, Kuross SA, Mailliard JA, Kugler JW, Schaefer PL, and Jett JR
- Subjects
- Antineoplastic Combined Chemotherapy Protocols administration & dosage, Carcinoma, Non-Small-Cell Lung pathology, Carcinoma, Squamous Cell drug therapy, Carcinoma, Squamous Cell pathology, Carcinoma, Squamous Cell radiotherapy, Cisplatin administration & dosage, Etoposide administration & dosage, Female, Follow-Up Studies, Humans, Lung Neoplasms pathology, Male, Prospective Studies, Radiotherapy adverse effects, Radiotherapy Dosage, Survival Analysis, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Carcinoma, Non-Small-Cell Lung drug therapy, Carcinoma, Non-Small-Cell Lung radiotherapy, Lung Neoplasms drug therapy, Lung Neoplasms radiotherapy
- Abstract
Purpose: This Phase III study was performed to determine whether chemotherapy plus b.i.d. or q.d. radiotherapy (RT) resulted in superior survival for patients with Stage III non-small-cell lung cancer (NSCLC)., Methods and Materials: Patients with Stage III NSCLC and an Eastern Cooperative Oncology Group performance status of
- Published
- 2002
- Full Text
- View/download PDF
16. Small cell lung cancer: current therapy and promising new regimens.
- Author
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Okuno SH and Jett JR
- Subjects
- Carcinoma, Small Cell radiotherapy, Combined Modality Therapy, Cranial Irradiation, Humans, Lung Neoplasms radiotherapy, Neoplasm Staging, Salvage Therapy, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Carcinoma, Small Cell drug therapy, Lung Neoplasms drug therapy
- Abstract
In this review, we cover current therapy and promising new regimens and highlight areas where improvement is needed in the management of small cell lung cancer.
- Published
- 2002
- Full Text
- View/download PDF
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