National Cancer Institute®
Last Modified: March 1, 2002
UI - 11723745
AU - Furuse K; Kawahara M; Hasegawa K; Kudoh S; Takada M; Sugiura T; Ichinose
TI - Y; Fukuoka M; Ohashi Y; Niitani H; S-1 Cooperative Study Group (Lung Cancer Working Group) Early phase II study of S-1, a new oral fluoropyrimidine, for advanced non-small-cell lung cancer.
SO - Int J Clin Oncol 2001 Oct;6(5):236-41
AD - Division of Respiratory Diseases, Health Insurance Union Osaka Central Hospital, 3-3-17 Niwashirodai, Sakai, Osaka 590-0133, Japan. firstname.lastname@example.org
BACKGROUND: The efficacy and safety of S-1, a new oral fluoropyrimidine, were evaluated in patients with non-small-cell lung cancer (NSCLC). The objective of this study was to determine whether the drug should be investigated in a late phase II study. METHODS: Each treatment course consisted of an oral dose of S-1, 50 mg/body or 75 mg/body, twice a day for 28 days followed by a 2-week washout period. RESULTS: Fifty-six eligible patients were enrolled. Five of the 40 previously untreated patients (12.5%; 90% confidence interval, 6.2%-23.5%) showed a partial response (PR), and no tumor response was observed in the 16 previously treated patients. The median survival duration in all eligible patients was 8.4 months, with a 1-year survival rate of 27.3%. The incidences of grade 3 or more severe adverse effects were: anemia, 5.4%; leukopenia, 5.4%; neutropenia, 5.4%; thrombocytopenia, 1.8%; anorexia, 3.6%; diarrhea, 3.6%; and general fatigue, 5.4%. These effects disappeared after cessation of the drug or appropriate treatment. One patient died as a result of aggravated interstitial pneumonitis, but the relationship of this event to S-1 was not clear. CONCLUSION: S-1 showed modest activity with mild toxicity in the treatment of non-small-cell lung cancer. Based on this result, we will progress to the next stage of a late phase II study for advanced NSCLC, and a phase II study of S-1 and cisplatin for advanced gastric cancer. Final results will be reported as they are obtained.
UI - 11857398
AU - Kosmas C; Tsavaris NB; Makatsoris T; Onyenadum A; Vadiaka M;
TI - Stavroyianni N; Sepsas E; Dimitropoulos D; Rokana S; Kalofonos HP A phase I-II study of docetaxel-ifosfamide-cisplatin (DIP) combination chemotherapy regimen in advanced nonsmall cell lung cancer.
SO - Int J Cancer 2002 Mar 1;98(1):141-7
AD - Department of Medicine, Medical Oncology Unit, Helena-Venizelou Hospital, Athens, Greece. email@example.com
In an attempt to develop more effective chemotherapy regimens in advanced nonsmall cell lung cancer (NSCLC), we evaluated docetaxel-ifosfamide-cisplatin (DIP) based on our previous experience with paclitaxel-ifosfamide-cisplatin. Patients with advanced NSCLC (stages III-IV), WHO-PS< or =2, no prior chemotherapy and unimpaired hematopoietic and organ function were eligible. Chemotherapy was administered in successive dose levels (DLs) and included docetaxel (80-100 mg/m2 day 1), ifosfamide (4-5 g/m2) and cisplatin (80-100 mg/m2), both divided over days 1 and 2 every 21 days. G-CSF (lenograstin) was administered from days 4-13. Fifty-five patients were accrued (phase I: 15; phase II: 40) and all are evaluable for response and toxicity: median age = 58 (40-72); PS = 1 (0-2); gender = 48 males, 7 females; stages IIIA = 8, IIIB = 19, IV = 28; and histologies were adenocarcinoma (29), squamous (20), large cell (6). Metastatic sites at diagnosis included lymph nodes (33), bone (8), liver (6), brain (6), lung nodules (9), adrenals (7) and soft tissue (1). The dose-limiting toxicity (DLT) was reached at DL4 (Docetaxel: 100 mg/m2-Ifosfamide: 5 g/m2-Cisplatin: 100 mg/m2) consisting of 2 cases of febrile neutropenia (FN), and DL3 (Docetaxel: 100 mg/m2-Ifosfamide: 5 g/m2-Cisplatin: 80 mg/m2) was considered as the maximum tolerated dose (MTD) and recommended for further phase II testing. Among evaluable patients in phase II, 31/46 (67%; CI = 54-81%) responded; 4 were complete responses, 27 partial responses, 12 with stable disease and 3 with progressive disease. The median response duration was 7 months (2-21+), median time to progression (TTP) 8 months (1-23+) and median overall survival (OS) 13 months (2-23+). The 1-year survival was 57%. Grade (Gr) 3/4 toxicities included neutropenia 39/46 with 27 developing Gr4 (< or =7 days) and 20% FN managed successfully with broad-spectrum antibiotics, thrombocytopenia Gr3 3/46-Gr4 1/46, no Gr3 neuropathy, Gr1-2 CNS toxicity in 12, no renal toxicity, 15 Gr2 myalgias, 17 Gr2 diarrhea and 10 Gr3 vomiting. In the present phase I-II study, DIP appears highly active and tolerable in advanced NSCLC in the outpatient setting. Randomized comparisons to current standard 2-drug regimens will be warranted. Copyright 2001 Wiley-Liss, Inc.
UI - 11577757
AU - Yamamoto Y; Nishiyama Y; Fukunaga K; Satoh K; Fujita J; Ohkawa M
TI - 99mTc-MIBI SPECT in small cell lung cancer patients before chemotherapy and after unresponsive chemotherapy.
SO - Ann Nucl Med 2001 Aug;15(4):329-35
AD - Department of Radiology, Kagawa Medical University, Japan. firstname.lastname@example.org
We evaluated the accumulation of 99mTc-MIBI in small cell lung cancer patients before chemotherapy and after unresponsive chemotherapy. The pre-chemotherapeutic group included 22 newly diagnosed patients. These patients underwent a 99mTc-MIBI SPECT study before starting chemotherapy. After chemotherapy, based on changes in tumor size, three different patterns of response (complete remission: CR, partial remission: PR and no change: NC) were defined. The post-chemotherapeutic group included 11 patients after chemotherapy who did not respond to chemotherapy. These patients underwent a 99mTc-MIBI SPECT study after completion of chemotherapy. SPECT images were acquired 15 min (early) and 2 hr (delayed) after injection of 99mTc-MIBI. With a region of interest technique, the early ratio, delayed ratio and retention index were calculated. Early and delayed ratios in pre-chemotherapeutic patients were significantly higher than those in post-chemotherapeutic patients. There were no significant differences between the pre-chemotherapeutic and post-chemotherapeutic patients in the retention index. In the pre-chemotherapeutic patients, early and delayed ratios for the CR and PR groups were significantly higher than those for the NC group. There were no significant differences in the retention index with respect to the tumor response. 99mTc-MIBI might be useful for evaluating the tumor chemosensitivity in patients with small cell lung cancer.
UI - 11872281
AU - Lee JS; Scott CB; Komaki R; Ettinger DS; Sause WT
TI - Impact of institutional experience on survival outcome of patients undergoing combined chemoradiation therapy for inoperable non-small-cell lung cancer.
SO - Int J Radiat Oncol Biol Phys 2002 Feb 1;52(2):362-70
AD - University of Texas M. D. Anderson Cancer Center, Houston, TX 77030, USA. email@example.com
PURPOSE: Clinical experience of both physicians and institutions has been shown to significantly influence the outcome of patients. We conducted this retrospective cohort study to examine its impact on the outcome of patients undergoing combined chemoradiation therapy for the treatment of locally advanced inoperable non-small-cell lung cancer. METHODS AND MATERIALS: We compared the clinical data from 239 patients who were enrolled in two consecutive Radiation Therapy Oncology Group (RTOG) trials (RTOG 91-06, RTOG 92-04) according to the number of patients enrolled from each institution in either trial alone or the two trials combined. RESULTS: Overall, patients treated at the institutions that enrolled > or = 5 patients survived longer than those treated at the institutions that enrolled <5 patients (median survival 20.5 vs. 13.4 months, p = 0.0006) with a more than doubling of the 2- and 3-year survival rates (45% and 31% vs. 20% and 13%, respectively). Multivariate analyses confirmed that the number of patients enrolled from each institution was an important prognostic factor for the entire group (p = 0.001) and also for RTOG 91-06 (p = 0.05) and RTOG 92-04 (p = 0.004) when the data were analyzed separately. CONCLUSION: Institutional experience has a significant impact on the survival outcome of patients undergoing combined chemoradiation therapy for inoperable non-small cell lung cancer.
UI - 11561693
AU - Kuebler JP; King GW; Triozzi P; Moore T; Kraut EH
TI - Phase II study of pyrazoloacridine in metastatic renal cell carcinoma.
SO - Invest New Drugs 2001;19(4):327-8
AD - Grant/Riverside Hospital, Columbus, OH, USA.
UI - 11561694
AU - Vokes EE; Gordon GS; Rudin CM; Mauer AM; Watson S; Krauss S; Arrieta R;
TI - Golomb HM; Hoffman PC A phase II trial of 9-aminocaptothecin (9-AC) as a 120-h infusion in patients with non-small cell lung cancer.
SO - Invest New Drugs 2001;19(4):329-33
AD - Department of Medicine and Cancer Research Center, University of Chicago, IL, USA. firstname.lastname@example.org
In a previous phase II trial of the synthetic topoisomerase I inhibitor, 9-aminocamptothecin (9-AC), given as a 72-h infusion, we identified modest single agent activity of 9% in patients with previously untreated advanced non-small cell lung cancer (NSCLC). Preclinical studies suggested that a more prolonged continuous infusion of the drug might lead to greater antitumor activity. A phase I study recommended a phase II dose of 25 microg/m2/hr for 120 h (3000 microg/m2 over 5 days), administered for 2 consecutive weeks of a 3-week cycle. We utilized this schedule and enrolled 13 chemotherapy-naive patients with Stage IIIB and IV NSCLC in this trial: median age 67 (range 57-74); 46% male; 92% stage IV; and median performance status 1. Twelve patients are available for response and toxicity evaluation after 2 cycles of therapy. One patient achieved a partial response. Four patients had stable disease while seven patients had progressive disease. Patients with stable or progressive disease after two cycles received no additional 9-AC, and were offered conventional chemotherapy. The median survival time was 10.2 months and the one-year survival rate 28% (95% confidence interval, 5-58%). Significant toxicities included myelosuppression, fatigue, and anorexia. One patient had grade 4 neutropenia following the first week of cycle 2, and did not receive additional therapy. There were no neutropenia-related infections. These data suggest that this prolonged schedule is unlikely to increase 9-AC's very modest activity in NSCLC above that seen with the simpler 72-h administration schedule. Further evaluation of 9-AC in NSCLC is not recommended.
UI - 11870504
AU - Yang CH; Tsai CM; Wang LS; Lee YC; Chang CJ; Lui LT; Yen SH; Hsu C;
TI - Cheng AL; Liu MY; Chiang SC; Chen YM; Luh KT; Huang MH; Yang PC; Perng RP Gemcitabine and cisplatin in a multimodality treatment for locally advanced non-small cell lung cancer.
SO - Br J Cancer 2002 Jan 21;86(2):190-5
AD - Department of Oncology and Cancer Research Center, National Taiwan University Hospital, College of Medicine, National Taiwan University, 7, Chung-Shan South Road, Taipei, 10016, Taiwan.
The role of new cytotoxic agents like gemcitabine has not yet been proven in the neoadjuvant settings. We designed a phase II study to test the feasibility of using gemcitabine and cisplatin before local treatment for stage III non-small cell lung cancer patients. Patients received three cycles of induction chemotherapy of gemcitabine (1000 mg m(-2), days 1, 8, 15) and cisplatin (90 mg m(-2), day 15) every 4 weeks before evaluation for operability. Operable patients underwent radical resection. Inoperable patients and patients who had incomplete resection received concurrent chemoradiotherapy with daily low dose cisplatin. All patients who did not progress after local treatment received three more cycles of adjuvant chemotherapy of gemcitabine and cisplatin. Fifty-two patients received induction treatment. Two patients had complete response and 31 patients had partial response (response rate 63.5%) after induction chemotherapy. Thirty-six patients (69%) were operable. Eighteen patients (35%) had their tumours completely resected. Two patients had pathological complete response. Median overall survival was 19.1 months, projected 1-year survival was 66% and 2-year survival was 34%. Three cycles of gemcitabine and cisplatin is effective and can be used as induction treatment before surgery for locally advanced non-small cell lung cancer patients. Copyright 2002 The Cancer Research Campaign
UI - 11830607
AU - Langer CJ; Manola J; Bernardo P; Kugler JW; Bonomi P; Cella D; Johnson
TI - DH Cisplatin-based therapy for elderly patients with advanced non-small-cell lung cancer: implications of Eastern Cooperative Oncology Group 5592, a randomized trial.
SO - J Natl Cancer Inst 2002 Feb 6;94(3):173-81
AD - C. J. Langer, Fox Chase Cancer Center, Philadelphia, PA 19111, USA. CJ_Langer@fccc.edu
BACKGROUND: Older patients, even if fit, are often considered incapable of tolerating platinum-based systemic therapy. We performed a retrospective analysis of Eastern Cooperative Oncology Group (ECOG) 5592, a phase III randomized trial of platinum-based chemotherapy regimens for non-small-cell lung cancer (NSCLC), and compared outcomes in enrollees 70 years of age and older with those in younger patients. METHODS: ECOG carried out a randomized phase III trial of cisplatin plus either etoposide or paclitaxel in chemotherapy-naive NSCLC patients with stages III(B) or IV disease. Toxic effects, response rates, and survival rates were compared between age groups. All P values were two-sided. older. Older patients had a higher incidence of cardiovascular (P =.009) and respiratory (P =.04) comorbidities and nonanalgesic medication use (P =.02). Leukopenia (P<.001) and neuropsychiatric toxicity (P =.002) were more common in elderly men than in younger men. Elderly women lost more weight than younger women (P =.006). Other toxic effects were similar in older and younger patients. The proportions with clinical partial or complete response (21.5% versus 23.3%; Fisher's exact test, P =.66), median time to progression (4.37 versus 4.30 months; log-rank test, P =.29), and survival distribution (log-rank test, P =.29; median survival, 9.05 versus 8.53 months; 1-year survival, 38% versus 29%; and 2-year survival, 14% versus 12%) were similar in patients younger than 70 years and 70 years old or older. Baseline quality-of-life and treatment-outcome indices were similar. Equivalent declines over time in functional well-being occurred in both groups. CONCLUSION: Response rate, toxicity, and survival in fit, elderly NSCLC patients receiving platinum-based treatment appear to be similar to those in younger patients, although patients 70 years old or older have more comorbidities and can expect more leukopenia and neuropsychiatric toxicity. Advanced age alone should not preclude appropriate NSCLC treatment.
UI - 11849815
AU - Jenkins P
TI - In regard to Rosenzweiz et al. IJROBP 2001;50:681-685.
SO - Int J Radiat Oncol Biol Phys 2002 Mar 1;52(3):878
UI - 11892374
AU - Anonymous
TI - Chemotherapy and non-small-cell lung cancer.
SO - Drug Ther Bull 2002 Feb;40(2):9-11
Around 34,000 people in the UK die from lung cancer each year. Over 75% of patients with the disease have non-small-cell lung cancer (NSCLC). Here, we discuss the role of chemotherapy in the management of NSCLC, a treatment that some medical oncologists estimate would benefit 50% of patients with NSCLC, but which is given to fewer than 10%.
UI - 11890096
AU - Mitsudomi T
TI - Molecular lesions as targets for diagnosis and therapy of lung cancer.
SO - Gan To Kagaku Ryoho 2002 Feb;29 Suppl 1():112-6
AD - Department of Thoracic Surgery, Aichi Cancer Center Hospital, 1-1 Kanokoden, Chikusa-ku, Nagoya 464-8681, Japan. email@example.com
Alteration of the p53 tumor suppressor gene is one of the most frequently seen molecular lesions in human lung cancer. It is of importance to integrate translational science into clinical practice. In our laboratory, we are in search for clinical utility of p53 gene alterations in management of patients with lung cancer. Here, we would like to discuss p53 alterations as a prognostic factor for lung cancer patients or as a predictor of chemosensitivity.
UI - 11890097
AU - Chu DT; Zhang XR; Li JL; Qu FL; Sun Y
TI - The treatment of advanced non-small-cell lung cancer (NSCLC)--overseas updated and local experiences.
SO - Gan To Kagaku Ryoho 2002 Feb;29 Suppl 1():117-24
AD - Cancer Institute and Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing 100021.
UI - 11824324
AU - Hillejan L; Muller MR; Eberhardt W; Stuben G; Stamatis G
TI - [Neoadjuvant chemotherapy and chemoradiotherapy in surgically treated non-small-cell stage III bronchial carcinoma]
SO - Kongressbd Dtsch Ges Chir Kongr 2001;118():601-5
AD - Ruhrlandklinik Essen, Tuschenerweg 40, 45239 Essen.
Patients with unfavorable stages of lung cancer are rarely cured with local treatment modalities alone. Aim of our phase II trial was to investigate the effectivity of a multimodality treatment. Ninety-four patients with NSCLC (stage IIIA/IIIB) were treated preoperatively with chemoradiotherapy (cisplatin and etoposide, 45 Gy hyperfractionated accelerated radiotherapy). After repeat mediastinoscopy patients underwent surgery. Complete resection (R0) was achieved in 53% of all patients with NSCLC. Two patients died of sepsis preoperatively and four postoperatively (90-days lethality: 6.4%). The median survival time was 20 months for IIIA and 18 months for IIIB. Calculated survival rates at 6 years were 34% for IIIA and 17% for IIIB. This multimodality treatment demonstrates high efficacy in prognostically unfavorable NSCLC compared with historical controls.
UI - 11824325
AU - Serke M; Allica E; Wolf M; Schonfeld N; Kaiser D; Loddenkemper R
TI - [Non-small-cell bronchial carcinoma with pathological N2 involvement: adjuvant radiotherapy versus adjuvant chemo-radiotherapy]
SO - Kongressbd Dtsch Ges Chir Kongr 2001;118():606-10
AD - Abteilung fur Pneumologie, Zentralklinik Emil von Behring, Dept. Lungenklinik Heckeshorn, Zum Heckeshorn 33, 14109 Berlin.
Fifty-eight patients, 28 of them included in a German multicenter study, were treated either with radiotherapy (5 x 2 Gy/50 Gy) or combined radio-chemotherapy (cisplatin 75 mg/m2 d1 in cases with pneumonectomy etoposide 120 mg/m2 d1-3) and Ifosfamid 1.5 mg/m2 d1-4, 3 cycles) following surgery in pN2-NSCLC. Metastatic disease or local failure was seen in 24 patients (43%), in the majority with distant metastasis (n = 21), in 4 patients combined local and distant failure. Time to progression (TTP) was 27 to 1172 days, median 244 days. Median survival of the whole group was 873 days (= 29 months), the 3-year survival 49%. Comparing the two groups there was an advantage (not significant) in favor of the combined treated group with a median survival of 1449 days versus 765 days (p = 0.22).
UI - 11854391
AU - Ramsey SD; Moinpour CM; Lovato LC; Crowley JJ; Grevstad P; Presant CA;
TI - Rivkin SE; Kelly K; Gandara DR Economic analysis of vinorelbine plus cisplatin versus paclitaxel plus carboplatin for advanced non-small-cell lung cancer.
SO - J Natl Cancer Inst 2002 Feb 20;94(4):291-7
AD - Southwest Oncology Group Statistical Center, Fred Hutchinson Cancer Research Center, Seattle, WA 98109-1024, USA. firstname.lastname@example.org
BACKGROUND: It is increasingly important to have timely information about the economic impact of new cancer therapies in today's cost-conscious environment. Nearly 170 000 people are diagnosed with lung cancer annually in the United States. We performed an economic analysis alongside Southwest Oncology Group Trial S9509 to estimate the cost-effectiveness of cisplatin plus vinorelbine versus carboplatin plus paclitaxel for patients with advanced non-small-cell lung cancer. There were no statistically significant differences in survival or cancer-related quality of life between the treatment arms. METHODS: Use of both protocol and nonprotocol lung cancer-related health care was tracked for 24 months from the initiation of therapy. To determine expenditures, nationally standardized costs were applied to each type of health care service used, and these were summed over time. Lifetime expenditures and 95% confidence intervals (CIs) for each arm of the trial were calculated with the use of a multivariate regression technique that accounts for censoring. Student's t tests were used to compare the difference in costs between the arms. All statistical tests were two-sided. RESULTS: Cancer-related health care costs over the period of observation averaged 40,292 dollars (95% CI = 36,226 dollars to 44,359 dollars) for patients in the cisplatin plus vinorelbine arm versus 48,940 dollars (95% CI = 44,674 dollars to 53,208 dollars) for patients in the carboplatin plus paclitaxel arm (P =.004), with a mean difference of 8648 dollars (95% CI = 2634 dollars to 14,662 dollars). Protocol chemotherapy drugs and medical procedures costs were statistically significantly higher in the paclitaxel arm (P =.0003 and P<.0001, respectively), whereas protocol chemotherapy delivery costs were statistically significantly higher in the vinorelbine arm (P<.0001). There was no difference between the arms in costs for blood products, supportive care medications, nonprotocol-related inpatient or outpatient care, and nonprotocol chemotherapy. CONCLUSIONS: Treatment with carboplatin plus paclitaxel is substantially and statistically significantly more expensive than treatment with cisplatin plus vinorelbine. The majority of the cost difference is due to the additional cost of the protocol chemotherapy (approximately 12,000 dollars). Notable differences in costs of downstream health care were not apparent.
UI - 11789188
AU - Fan G; Zong W; Zuo J
TI - [Dynamic observation and clinical significance of integrated traditional Chinese and Western medicine on interleukin-2 system, T cell and erythrocyte immune system in patients of lung cancer]
SO - Zhongguo Zhong Xi Yi Jie He Za Zhi 2000 Aug;20(8):586-8
AD - Affiliated Subei Hospital, Medical College of Yangzhou University, Jiangsu (225001).
OBJECTIVE: To study the dynamic changes and its clinical significance of integrated traditional Chinese and western medicine (TCM-WM) on IL-2 system, T cell and erythrocyte immune system in patients of lung cancer. METHODS: Forty-eight cases with lung cancer were randomly divided into two groups: TCM-WM group (group I) and the chemotherapy group (group II); and 20 healthy subjects were simultaneously compared. The relevant immune indices, clinical symptoms and signs, changes of solid tumor and living quality were dynamically observed. RESULTS: (1) The serum IL-2 level of lung cancer patients were significantly lower, while sIL-2R level higher than that of the healthy subjects. And they were raised and lowered respectively after treatment, especially in the group I, but different from the control group yet. And there were highly negative correlation between IL-2 and sIL-2R levels. (2) The percentage of CD3, CD4 and the ratio CD4/CD8 were decreased markedly in both groups, except CD8 which was increased markedly. And the percentage of RBC-C3b RR was obviously lower, while that of RBC-ICR was obviously higher. But the above-mentioned indices could be improved after treatment, especially in the group I, and there were highly positive correlation between CD4/CD8 ratio and RBC-C3bRR. (3) After treatment, all above-mentioned indices were changed significantly to their corresponding opposites. However, in regard to the degree of improvement, the patients of group I were in a better position than those of group II. At the same time, improvement of their clinical symptoms and signs, change of solid tumor and living quality also showed advantageous. CONCLUSION: The therapeutic superiority of TCM-WM on lung cancer may be related with the modulation on immune function. Thus we can say that the effect of TCM-WM is better than that of chemotherapy alone.
UI - 11902490
AU - Hotta K; Sekine I; Tamura T; Sawada M; Watanabe H; Kusaba H; Akiyama Y;
TI - Inoue A; Shimoyama T; Nokihara H; Ueda Y; Yamamoto N; Kunitoh H; Ohe Y; Kodama T; Saijo N A phase I/II study of cisplatin and vinorelbine chemotherapy in patients with advanced non-small cell lung cancer.
SO - Jpn J Clin Oncol 2001 Dec;31(12):596-600
AD - Division of Medical Oncology, National Cancer Center Hospital, Tokyo, Japan.
BACKGROUND: A combination of cisplatin and vinorelbine chemotherapy is effective in cases of advanced non-small cell lung cancer, but the optimum administration schedule for both drugs has not yet been defined. The aim of this study was to determine the maximum dose of vinorelbine that can be tolerated while receiving a fixed dose of cisplatin every 3 weeks and to observe the response in Japanese patients with advanced non-small cell lung cancer who had not previously received chemotherapy. METHODS: Cisplatin was given at a dose of 80 mg/m2 on day 1. Vinorelbine was administered on days 1 and 8 at a starting dose of 25 mg/m2 that was then increased by 5 mg/m2 increments. This treatment was repeated every 3 weeks. RESULTS: Twenty-one patients received a total of 54 chemotherapy cycles consisting of three different vinorelbine dosages. Toxicity and efficacy were evaluated in all of the patients. The main dose-limiting toxicity was neutropenia. Grades 3-4 leukopenia and neutropenia were observed in 57% and 86% of all cycles, respectively. These conditions were reversible and did not result in death from toxicity. The most severe non-hematological toxicity symptom was a grade 3 infection and reaction at the site of injection. The maximum tolerated dose of vinorelbine was 35 mg/m2. The objective response was noted in one of six patients at dose level 1, in four of 12 patients at dose level 2 and in two of three patients at dose level 3. CONCLUSION: The recommended doses were 80 mg/m2 for cisplatin and 30 mg/m2 for vinorelbine. The combination of cisplatin and vinorelbine repeated every 3 weeks is well tolerated and has shown promising anti-tumor activity against non-small cell lung cancer.
UI - 11751486
AU - Fidias P; Supko JG; Martins R; Boral A; Carey R; Grossbard M; Shapiro G;
TI - Ostler P; Lucca J; Johnson BE; Skarin A; Lynch TJ A phase II study of weekly paclitaxel in elderly patients with advanced non-small cell lung cancer.
SO - Clin Cancer Res 2001 Dec;7(12):3942-9
AD - Division of Hematology-Oncology, Massachusetts General Hospital, 100 Blossom Street, Cox 201, Boston, MA 02114, USA. Pfidias2@Partners.org
PURPOSE: Our aim was to evaluate the efficacy, toxicity, and pharmacokinetic behavior of single-agent paclitaxel given weekly to elderly patients with lung cancer. EXPERIMENTAL DESIGN: Previously untreated patients with stage IIIB/IV non-small cell lung cancer were eligible for the study if they were at least 70 years of age and had preserved organ function. Paclitaxel was administered over 1 h at a dose of 90 mg/m(2) for 6 consecutive weeks on an 8-week cycle. The pharmacokinetics of paclitaxel were assessed during the first and sixth week of therapy in a subgroup of eight patients. RESULTS: A total of 35 patients (median age, 76 years; range, 70-85) were enrolled. The overall response rate was 23%. Median time to failure was 5.2 months, whereas the median survival time was 10.3 months. Survival rates after 1 and 2 years were 45 and 22%, respectively. Grade 3/4 toxicities included neutropenia (5.8%), hyperglycemia (17.6%), neuropathy (5.8%), and infection (8.8%). Two patients died from treatment-related toxicity. There was no significant difference (P = 0.18) between the total body clearance of paclitaxel on the first (17.4 +/- 2.9 liters/h/m(2), mean +/- SD) and sixth (15.8 +/- 4.1 liters/h/m(2)) week of therapy. CONCLUSION: Paclitaxel administered as a weekly 1-h infusion at a dose of 90 mg/m(2) is a safe and effective therapy for elderly patients with advanced non-small cell lung cancer. Its pharmacokinetics in elderly patients do not appear to differ from historical data for younger patients, and there was no suggestion of a change in drug clearance after repeated weekly dosing.
UI - 11864800
AU - Cella D; Eton DT; Fairclough DL; Bonomi P; Heyes AE; Silberman C; Wolf
TI - MK; Johnson DH What is a clinically meaningful change on the Functional Assessment of Cancer Therapy-Lung (FACT-L) Questionnaire? Results from Eastern Cooperative Oncology Group (ECOG) Study 5592.
SO - J Clin Epidemiol 2002 Mar;55(3):285-95
AD - Evanston Northwestern Healthcare & Northwestern University, 1001 University Place, Suite 100, Evanston, IL 60201, USA. email@example.com
To assess the impact of disease and treatment on patients with advanced non-small cell lung cancer (NSCLC), we set out to determine a clinically meaningful change (CMC) on the Lung Cancer Subscale (LCS) and the Trial Outcome Index (TOI) of the Functional Assessment of Cancer Therapy-Lung (FACT-L) questionnaire. We used data from Eastern Cooperative Oncology Group study 5592 (E5592), a randomized trial comparing three chemotherapeutic regimens in 599 advanced NSCLC patients. Patients completed the FACT-L at baseline (pretreatment), 6 weeks, 12 weeks, and 6 months. Comparing across baseline performance status (0 vs. 1), prior weight loss (<5% vs. > or = 5%), and primary disease symptoms (< or = 1 vs. >1), LCS and TOI score differences ranged from 2.4 to 3.6 and 6.5 to 9.2, respectively (all Ps <.001). Mean improvement in LCS score from baseline to 12 weeks was 2.4 points in patients who had responded to treatment versus 0.0 points in patients who had progressive disease. Twelve-week LCS change scores for patients progressing early were 3.1 points worse than those of patients progressing later (mean = -1.2 vs.1.9, respectively). Similarly, the average TOI change score from baseline to 12 weeks was -6.1 for patients who had progressive disease versus -0.8 points for patients who had responded to treatment. Twelve-week TOI change scores for patients progressing early (mean = -8.1) were 5.7 points worse than those of patients progressing later (mean = -8.1 vs. -2.4, respectively). Analyses assuming nonrandom missing data resulted in slightly larger differences. Clinically relevant change scores were estimated as two to three points for the LCS and five to seven points for the TOI, setting upper limits for minimal CMCs. These values were comparable to suggested distribution-based criteria of a minimally important difference. These results support use of a two to three point change in the LCS and five to six point change on the TOI of the FACT-L as a CMC, and offer practical direction for inclusion of important patient-based endpoints in lung cancer clinical trials.
UI - 11870532
AU - Date H; Kiura K; Ueoka H; Tabata M; Aoe M; Andou A; Shibayama T; Shimizu
TI - N Preoperative induction chemotherapy with cisplatin and irinotecan for pathological N(2) non-small cell lung cancer.
SO - Br J Cancer 2002 Feb 12;86(4):530-3
AD - Department of Surgery II, Okayama University School of Medicine, 2-5-1 Shikata-cho, Okayama 700-8558, Japan. firstname.lastname@example.org
We conducted a phase I/II study to investigate whether the surgical resection after induction chemotherapy with cisplatin and irinotecan was feasible and could improve the treatment outcome for patients with pathological N(2) non-small cell lung cancer. Fifteen patients with stage IIIA non-small cell lung cancer having mediastinal lymph node metastases proved by mediastinoscopy were eligible. Both cisplatin (60 mg m(-2)) and irinotecan (50 mg m(-2)) were given on days 1 and 8. Patients received two cycles of chemotherapy after 3-4 weeks interval. Induction was followed by surgical resection in 4-6 weeks. Patients who had documented tumour regression after preoperative chemotherapy received two additional cycles of chemotherapy and other patients received radiotherapy postoperatively. After the induction chemotherapy, the objective response rate was 73%. All the 15 patients received surgical resection and complete resection was achieved in 11 (73%) patients. There was no operation-related death and one death due to radiation pneumonitis during postoperative radiotherapy. The median time from entry to final analysis was 46.5 months, ranging from 22 to 68 months. The 5-year survival rate was 40% for all the 15 patients and it was 55% for the 11 patients who underwent complete resection. We conclude that the surgical resection after induction chemotherapy with cisplatin and irinotecan is feasible, and associated with low morbidity and high respectability.
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