Stage IIIB-IV Non-small Cell Lung Research Articles

Comparison of vinorelbine-Cisplatin with gemcitabine-Cisplatin in patients with advanced non-small cell lung cancer.

The objective of this trial was to compare cisplatin-plus-vinorelbine regimen with cisplatin-plus-gemcitabine regimen in patients with stage IIIB-IV non-small cell lung cancer (NSCLC). Chemonaive patients with stage IIIB-IV NSCLC received either vinoelbine 30 mg/m(2) (days 1 and 8) plus cisplatin 80 mg/m(2) (day 1) every 21 days (VC arm) or gemcitabine 1250 mg/m(2) (days 1 and 8) plus cisplatin 80 mg/m(2) (day 1) every 21 days (GC arm). One hundred thirtyfour patients (67 VC and 67 GC) were included to the study. Overall response rates for the VC arm (31.2%) were not significantly different from that of the GC arm (34.3%). There were no differences in overall survival and one-year survival rates. Median survival and one-year survival rates for the VC and GC groups were 10.6 and 11.5 months, 45% and 46.8%, respectively. Grade 3-4 thrombocytopenia was significantly higher on the GC arm (VC 1.4% v GC 8.9%, p < 0.05), as was febrile neutropenia on the VC arm (VC 8.9% v GC 1.4%, p < 0.05). VC and GC demonstrated similar efficacy but there were differences in toxicity profiles.

Prise en charge des cancers bronchiques non à petites cellules après docétaxel-cisplatine: Résultats d’une étude observationnelle

The purpose of this epidemiologic survey was to describe the management of second-line therapy for patients with stage IIIB-IV non-small cell lung carcinoma (NSCLC) following docetaxel-cisplatin as first-line therapy.Between June 2003 and December 2004, 265 patients were enrolled. The data registered were the choice of cytotoxics, the safety profile, the efficacy and the clinical benefit.Two hundred and sixty one patients were treated with docetaxel-cisplatin as a first-line regimen and 181 received a second line. This second line was a single agent regimen in 58% of cases and a gemcitabine based treatment in 60.8%. The main criterion for the choice of second-line therapy was the safety profile in 34.3% of cases. The overall response rate was 16.6% after the second line and clinical benefit was reported in 43.6% of patients.In more than 2/3 of patients with NSCLC the docetaxel-cisplatin combination leaves the opportunity to give a second-line treatment, providing satisfying results in terms of clinical benefit. In this study gemcitabine was the most widely prescribed second-line treatment, mainly as a single agent.

A3-06: Triplets versus doublets with or without cisplatin in the first-line treatment of stage IIIB-IV non-small cell lung cancer (NSCLC) patients: preliminary results of a multicenter randomized factorial study

A3-06: Triplets versus doublets with or without cisplatin in the first-line treatment of stage IIIB-IV non-small cell lung cancer (NSCLC) patients: preliminary results of a multicenter randomized factorial study

Phase II trial of weekly paclitaxel and gemcitabine for previously untreated, stage IIIB‐IV nonsmall cell lung cancer

The purpose of the current study was to evaluate the efficacy and tolerance of the noncisplatin-based combination of paclitaxel and gemcitabine administered weekly for patients with untreated metastatic nonsmall cell lung cancer (NSCLC). Patients with Stage IIIB/IV or recurrent NSCLC, a performance status of 0-2, and no prior chemotherapy exposure were eligible. Patients received gemcitabine 1000 mg/m2 and paclitaxel 85 mg/m2 on Days 1, 8, 15, 22, 29, 36 of an 8-week cycle until progression. Thirty-nine eligible patients were enrolled. The median age was 66 years and 14 patients were > or =70 years old. Performance status was 2 in 13 (33%) and 29 patients (75%) had Stage IV. Five patients (12.8%) developed interstitial pneumonitis and 2 of these were responsive to steroid therapy. The overall response rate was 23.1%, with no complete responses. The median survival was 32 weeks and the 1-year survival was 32%. This regimen of weekly paclitaxel and gemcitabine has modest activity in advanced NSCLC.

Randomized study of vinorelbine–gemcitabine versus vinorelbine–carboplatin in patients with advanced non-small cell lung cancer

The objective of this trial was to compare two vinorelbine-based doublets with carboplatin (CBDCA-VC) or with gemcitabine (VG) in patients with stage IIIB-IV non-small cell lung cancer (NSCLC). A total of 316 patients with advanced NSCLC previously untreated were randomized to either vinorelbine 30 mg/m(2) D1,8 with carboplatin AUC 5 D1 (VC) or vinorelbine 25mg/m(2) with gemcitabine (VG) 1000 mg/m(2) both given D1,8 every 3 weeks. The primary endpoint was response rate with secondary parameters being survival (OS), progression-free survival (PFS), tolerance and clinical benefit. The median number of cycles was four in each arm with a total of 1268 cycles. The objective response (OR) on intent-to-treat was 20.8% in VC and 28% in VG (p=0.15). Median PFS was 3.9 months in VC and 4.4 months (mo) in VG (p=0.18). Median survival was significantly longer (p=0.01) for VG with 11.5 mo compared to 8.6 mo in VC with 1 year survival at 48.9 and 34.4%, respectively. Tolerance was better in the VG arm as compared to the VC patients. Four toxic deaths were recorded in the VC group. Clinical benefit response rate was 32.4% compared to 40.9% in 111 and 110 evaluable patients in VC and VG, respectively. VG compared to VC resulted in a similar overall response rate, favourable median survival and a better toxicity profile. For non-cisplatin-based chemotherapy, VG is a useful alternative.

Phase II clinical trial of homemade human rh-endostatin in the treatment of patients with stage IIIB-IV non-small cell lung cancer

To evaluate the efficacy and safety of homemade human rh-endostatin (YH-16) combined with NP regimen (vinorelbine+cisplatin) for stage IIIB-IV non small cell lung cancer (NSCLC), and to compare with NP regimen alone. Eighteen NSCLC patients were divided into two groups. Group A ( n =9) received YH-16 combined with NP plan. Group B ( n =9) received NP regimen. They were treated with 2 or 3 cycles of chemotherapy. The overall response, time to progression (TTP), quality of life (QOL) and safety were observed. The overall response was 22.2% in group A, and 0% in group B ( P > 0.05). The clinical benefit rate was 100% in group A, and 44.4% in group B ( P < 0.05). There was no significant relationship between response and clinical pathological characteristics of patients ( P > 0.05). The TTP was 178.8±70.8 days in group A and 85.4±48.2 days in group B ( P < 0.05). The main toxicities of the two groups were hematological toxicities, nausea and vomiting. No significant difference in incidence of toxicity was observed between the two groups ( P > 0.05). The rh-endostatin combined with NP regimen for NSCLC tends to show a better chemotherapeutic effect and less toxicity than NP regimen alone. It is worthy of extensive clinical trial.

Three Conventional-Drug Combination (Ifosfamide, Carboplatin, Etoposide - ICE Regimen) in Advanced Non-Small Cell Lung Cancer (NSCLC)

Fifty consecutive patients with stage IIIB-IV non-small cell lung cancer (NSCLC) received the ICE regimen at intermediate doses (ifosfamide 1 g/m2, carboplatin 120 mg/m2, etoposide 80 mg/m2, day 1 to 3, q.4 weeks, for a maximum of 6 cycles). Overall 2 complete response (CR) and 10 partial response (PR) (overall response, OR: 24%, 95% C.I. 14-37%) were observed. An additional 7 patients had stable disease (SD) lasting more than 6 months, therefore a clinical benefit (CR+PR+SD >6 mos) was achieved in 19 patients (38%). Median time-to-progression (TTP) was 7 months and median overall survival (OS) was 11 months; 1- and 2-year survival rates were 36% and 10%. The ICE regimen was well tolerated and devoid of any cardiac, hepatic or neurologic toxicity. Moderate nausea and vomiting were easily manageable, grade 2 alopecia was universal, while hematological toxicity was mild (grade 2 leuko-and thrombocytopenia). Due to its efficacy and safety profile, this 3-drug regimen can be considered for routine community use.

Phase [formula omitted] study of gemcitabine (GEM) plus vinorelbine (NAV) in patients with stage IIIB-IV non-small cell lung cancer (NSCLC)

Phase [formula omitted] study of gemcitabine (GEM) plus vinorelbine (NAV) in patients with stage IIIB-IV non-small cell lung cancer (NSCLC)

Phase II study of weekly gemcitabine in advanced non-small cell lung cancer

New active agents are needed to develop effective systemic therapy against Stage IIIB-IV non-small cell lung cancer (NSCLC). The aim of the present study was to assess the efficacy and toxicity of gemcitabine, a novel nucleoside analogue with significant preclinical activity, as a single-agent therapy. Forty-three patients with previously untreated Stage IIIB-IV NSCLC were included. Gemcitabine was administered intravenously over 30 min on Days 1, 8 and 15 of each 28-day cycle at a dose of 1250 mg m −2. Thirty-seven patients were evaluable for response. There were seven partial responses giving an overall response rate of 19% (95% confidence interval 8–35%). Median duration of response was 6 months. One-year survival and median survival for all patients were 33% and 8 months, respectively. Toxicity of the treatment was mild. World Health Organization (WHO) Grade 3–4 leukopenia was detected in 11% of the patients. Mild (WHO Grade 1–2) nausea was the most frequent subjective side-effect with a rate of 82%. Mild rash and peripheral oedema were typical side-effects of gemcitabine with rates of 19 and 9%, respectively. In conclusion, single-agent gemcitabine is an active and well-tolerated treatment for Stage IIIB-IV NSCLC patients.

Phase II study with paclitaxel for the treatment of advanced inoperable non-small cell lung cancer

Paclitaxel is a plant product isolated from the bark of the Western yew (Taxus brevifolia) that promotes the formation and stabilization of microtubules. This leads to growth arrest in the G 2/M phase of the cell cycle. Paclitaxel has demonstrated significant antineoplastic activity in different tumor types, most notably in ovarian and breast carcinoma. In two Phase II trials (Eastern Cooperative Oncology Group [ECOG]/M.D. Anderson) in patients with previously untreated Stage IIIB-IV non-small cell lung cancer (NSCLC), response rates of 21% and 24% were reported. We are performing a Phase II trial investigating the efficacy of paclitaxel in patients with inoperable Stage IIIB-IV NSCLC. Forty-three patients were treated, 31 males and 12 females, with a median age of 59 years (range, 29–75), ECOG performance status 0-2, Stage HIB 30%, Stage IV 70%. Patients were treated every 3 weeks with 225 mg/m 2s a 3-h infusion with standard premedication. Preliminary efficacy results from 37 patients include partial remissions in eight (21.6%) patients, no change in 22 (59.5%) and disease progression in seven (19%) patients. Eight patients are still receiving therapy. The hematologic toxicities (n = 43) were mild, and no World Health Organization (WHO) Grade 4 neutropenia was observed. Nonhematologic toxicities were Grade 1/2 polyneuropathy in 97.6%, Grade 1-3 myalgia/arthralgia in 76%, and Grade 1-3 nausea/vomiting in 18.6% of the patients. In conclusion, paclitaxel is an active single agent in this patient population. Mild hematologic toxicities were observed in the 3-h infusion setting (compared with 24-h infusion) and therapy was well tolerated. Further Phase II studies with paclitaxel in combination with other drugs having shown activity in NSCLC are indicated, and the results from Phase III studies comparing paclitaxel with standard chemotherapy regimens remain to be seen.

Combination chemotherapy with vinorelbine, ifosfamide, and cisplatin: A phase II study in stage IIIB-IV non-small cell lung cancer: Baldini E, Tibaldi C, Chella A, Angeletti CA, Romanini A, Andrei A et al. Department of Medical Oncology, S. Chiara Hospital, Via Roma, 67, 56100 Pisa. Semin Oncol 1994;21:Suppl 4:12–15

Forty-five stage IIIB-IV non-small cell lung cancer (NSCLC) patients entered a phase II study designed to evaluate the toxicity and the activity of a combination chemotherapy regimen consisting of vinorelbine (25 mg/m2 days 1 and 8), ifosfamide (3 g/m2 day 1 with uroprotective mesna), and cisplatin (80 mg/m2 day 1). The regimen, VIP, was administered on an outpatient basis every 3 weeks. White blood cell counts were checked weekly, and granulocyte colony-stimulating factor was administered in case of grade 4 neutropenia lasting for more than 48 hours. Leukopenia was the most frequent toxicity, with grades 3 and 4 neutropenia reported in 25% of cycles and 11 episodes of febrile neutropenia recorded in 175 evaluable courses. The combination of vinorelbine and cisplatin did not result in additive neurotoxicity: only five patients experienced grade 2 neurotoxicity after six courses of treatment. Thirty-five patients were evaluable for response. Twenty partial responses (57%) and one complete response (2.8%) were observed, for an overall response rate of 60% (95% confidence interval, 42% to 76%). The median time to progression, measured from the start of treatment, was 7 months (range, 1 to 18+), and median survival for the whole group was 12 months (range, 1 to 18+). VIP is a well-tolerated regimen and shows interesting activity in advanced NSCLC.

Encouraging survival for stage IIIB-IV non-small cell lung cancer (NSCLC) patients after sequential treatment with ifosfamide, epirubicin, cisplatin and radiation therapy

Encouraging survival for stage IIIB-IV non-small cell lung cancer (NSCLC) patients after sequential treatment with ifosfamide, epirubicin, cisplatin and radiation therapy