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A Artal

Publications and source records attributed to A Artal.

At least 19 recordsLinked to original sources

Phase II trial of the novel taxane BMS-184476 as second-line in non-small-cell lung cancer.

BACKGROUND: The purpose of this study was to evaluate the tolerability and efficacy of BMS-184476, an analog of paclitaxel, in patients with advanced non-small-cell lung cancer (NSCLC) progressing or relapsing following at least one prior chemotherapy regimen. PATIENTS AND METHODS: Fifty-six previously treated advanced NSCLC patients received BMS-184476 at a dose of 60 mg/m(2) administered intravenously over 1 h every 21 days. RESULTS: The median number of cycles delivered per patient was five (range one to 17). Dose reduction was required in only 3.8% of cycles. Grade 4 neutropenia occurred in 19.6% of patients, but no grade 4 thrombocytopenia or anemia was reported. Febrile neutropenia was observed in only two (3.6%) patients and there were no life-threatening events. Grade 3/4 peripheral sensory-motor neuropathy was reported in 9% of patients. Other non-hematological toxicities, such as nausea and vomiting, myalgia and arthralgia, diarrhea, and mucositis, were uncommon. Partial responses were observed in eight (14.3%) patients and stable disease in 33 (58.9%). Median progression-free survival was 3.7 months [95% confidence interval (CI) 2.7-5.4] and median overall survival was 10 months (95% CI 6-13.4). CONCLUSIONS: BMS-184476 was well tolerated at the dose of 60 mg/m(2) and showed evidence of antitumor activity in previously treated NSCLC.

Adult↗

Single nucleotide polymorphisms and outcome in docetaxel-cisplatin-treated advanced non-small-cell lung cancer.

BACKGROUND: Platinum-based doublets are the standard chemotherapy for advanced non-small-cell lung cancer (NSCLC). Excision-repair cross-complementing 1 (ERCC1), xeroderma pigmentosum group D (XPD) and ribonucleotide reductase subunit M1 (RRM1) are essential to the repair of cisplatin DNA adducts. Multidrug resistance 1 (MDR1) has been related to antimicrotubule resistance. We assessed whether single nucleotide polymorphisms (SNPs) in ERCC1, XPD, RRM1 and MDR1, and ERCC1 mRNA expression, predicted survival in docetaxel-cisplatin-treated stage IV NSCLC patients. PATIENTS AND METHODS: Using the TaqMan 5' nuclease assay, we examined ERCC1 118, XPD 751 and 312, RRM1 -37C/A, and MDR1 C3435T SNPs in peripheral blood lymphocytes (PBLs) obtained from 62 docetaxel-cisplatin-treated advanced NSCLC patients. ERCC1 expression was measured in RNA isolated from PBLs using real-time reverse transcriptase PCR. RESULTS: Overall median survival was 10.26 months. Median survival was 9.67 months for 34 patients with ERCC1 118 C/T, 9.74 months for 17 patients with T/T, and not reached for 11 patients with C/C (P=0.04). Similar significant differences in time to progression were observed according to ERCC1 118 genotype (P=0.03). No other significant differences were observed. CONCLUSIONS: Patients homozygous for the ERCC1 118 C allele demonstrated a significantly better survival. ERCC1 SNP assessment could be an important component of tailored chemotherapy trials.

Adult↗

Cisplatin plus gemcitabine versus a cisplatin-based triplet versus nonplatinum sequential doublets in advanced non-small-cell lung cancer: a Spanish Lung Cancer Group phase III randomized trial.

PURPOSE: To compare the survival benefit obtained with cisplatin plus gemcitabine, a cisplatin-based triplet, and nonplatinum sequential doublets in advanced non-small-cell lung cancer (NSCLC). PATIENTS AND METHODS: Stage IIIB to IV NSCLC patients were randomly assigned to receive cisplatin 100 mg/m2 day 1 plus gemcitabine 1,250 mg/m2 days 1 and 8, every 3 weeks for six cycles (CG); cisplatin 100 mg/m2 day 1 plus gemcitabine 1,000 mg/m2 and vinorelbine 25 mg/m2 days 1 and 8, every 3 weeks for six cycles (CGV); or gemcitabine 1,000 mg/m2 plus vinorelbine 30 mg/m2 days 1 and 8, every 3 weeks for three cycles, followed by vinorelbine 30 mg/m2 days 1 and 8 plus ifosfamide 3 g/m2 day 1, every 3 weeks for three cycles (GV-VI). RESULTS: Five hundred fifty-seven patients were assigned to treatment (182 CG, 188 CGV, 187 GV-VI). Response rates were significantly inferior for the nonplatinum sequential doublet (CG, 42%; CGV, 41%; GV-VI, 27%; CG v GV-VI, P =.003). No differences in median survival or time to progression were observed. Toxicity was higher for the triplet: grade 3 to 4 neutropenia (GC, 32%; CGV, 57%; GV-VI, 27%; P <.05); neutropenic fever (CG, 4%; CGV, 19%; GV-VI, 5%; P <.0001); grade 3 to 4 thrombocytopenia (CG, 19%; CGV, 23%; GV-VI, 3%; P =.0001); and grade 3 to 4 emesis (GC, 22%; GCV, 32%; GV-VI, 6%; P <.0001). CONCLUSION: On the basis of these results, CG remains a standard regimen for first-line treatment of advanced NSCLC.

Adult↗

Three-week schedule of irinotecan and cisplatin in advanced non-small cell lung cancer: a multicentre phase II study.

A phase II multicentre study of a 3-week schedule of irinotecan (CPT-11) and cisplatin providing the highest recommended dose intensity of both agents in combination, was conducted in patients with advanced non-small cell lung cancer (NSCLC). Seventy-four stage IIIB (not suitable for radiotherapy) or stage IV NSCLC patients were enrolled to receive CPT-11 200 mg/m(2) i.v. and cisplatin 80 mg/m(2) i.v. on day 1 every 3 weeks. Relative dose-intensities for CPT-11 and cisplatin were 92 and 95%, respectively. No complete responses were observed. Twenty-five patients out of 73 obtained a partial response (34.2%). Partial responses were confirmed in 18 patients (24.7%: 95% CI, 15.3-36.1%). Median survival overall was 8.2 months, 9.7 months for patients with baseline performance status (PS) 0 and 1, and 4 months for patients with PS 2. The 1-year survival rate was 31%. Major clinical toxicities were grade 3 and 4 delayed diarrhoea (29% of patients) and febrile neutropenia (14% of patients). In conclusion, the present once-every-3-week schedule of CPT-11 and cisplatin is feasible and active in PS 0-1 advanced NSCLC patients, but results do not seem superior to those reported with other schedules.

Adenocarcinoma↗

Phase II trial of paclitaxel plus gemcitabine in patients with locally advanced or metastatic non-small-cell lung cancer.

PURPOSE: Given the cisplatin-related myelotoxicity and nonhematologic toxicities, we were prompted to undertake a study of the noncisplatin combination of paclitaxel plus gemcitabine to evaluate the efficacy, tolerance, and survival of this combination in patients with locally advanced and metastatic non-small-cell lung cancer (NSCLC). PATIENTS AND METHODS: Patients received gemcitabine 2,000 mg/m(2) and paclitaxel 150 mg/m(2) on days 1 and 15 of a 28-day cycle, for a maximum of eight cycles. RESULTS: Between December 1997 and June 1998, 89 untreated NSCLC patients were enrolled; 30 (34%) had stage IIIB disease (23 with malignant pleural effusion and seven without), and 59 (66%) had stage IV disease. Eighty-six percent of patients had a performance status of 0 or 1. The median number of cycles administered was four (range, one to eight cycles). The mean dose-intensity for both paclitaxel and gemcitabine was nearly 100%. Hematologic and nonhematologic toxicities were mild. Thirty-eight patients received second-line chemotherapy after completion of the study. The overall intent-to-treat response rate was 32.2%, with a higher response rate for stage IIIB patients (43.3%) than for stage IV patients (26.3%). Overall median survival was 9.9 months, and 1-year survival was 38.8% (14.2 months for stage IIIB and 7.7 months for stage IV; P =.007). Median survival was 10.2 months for patients with a performance status of 0 or 1 and 4.8 months for patients with a performance status of 2 (P =.007). CONCLUSION: A biweekly paclitaxel/gemcitabine regimen was well tolerated, with an acceptable response rate and a reasonable median survival time, especially in patients with good performance status. It merits further exploration in future studies.

Adult↗

Phase I trial of weekly gemcitabine at 3-h infusion in refractory, heavily pretreated advanced solid tumors.

Gemcitabine (2',2'-difluorodeoxycytidine) is a nucleoside analog with antitumor activity against a variety of malignancies. The critical enzyme cytidine kinase is saturated at plasma concentrations achieved after a 30-min infusion at conventional doses. Prolonged infusion time may yield higher intracellular dFdCTP concentrations. A phase I study was designed to determine the maximum tolerated dose (MTD) of gemcitabine, given by infusion for 3 h, in heavily pretreated patients. Twenty-seven patients (13 head and neck cancer, seven sarcoma, three esophageal cancer, three non-small-cell lung cancer and one ovarian cancer) were enrolled. Twenty patients were defined as refractory at first- or second-line chemotherapy. Four different entry dose levels (300, 400, 450 and 500 mg/m(2)) were evaluated for gemcitabine administered on days 1, 8 and 15 of a 28-day cycle. The MTD was defined as 450 mg/m(2), with granulocytopenia, thrombocytopenia and asthenia being dose limiting. The maximum grade III/IV patient toxicities for hemoglobin, leukocytes, neutrophils and platelets for all doses were 7, 19, 19 and 11%, respectively. Non-hematological toxicities included asthenia, nausea/vomiting and diarrhea. Thus, gemcitabine administered at a fixed 3-h infusion was well tolerated up to 450 mg/m(2) in heavily pretreated patients. Myelosupression and asthenia were dose-limiting toxicities.

Adult↗

Prognostic impact of bulky mediastinal lymph nodes (N2>2.5 cm) in patients with locally advanced non-small-cell lung cancer (LA-NSCLC) treated with platinum-based induction chemotherapy.

A group of 70 patients with locally advanced non-small-cell lung cancer (LA-NSCLC), treated in different phase II-III trials with platinum-based chemotherapy in two institutions, have been evaluated to identify potential baseline prognostic factors predicting their survival. The eligibility criteria were patients with stage IIIA (N2)-IIIB, Eastern Cooperative Oncology Group performance status 0.1 and less than 5% weight loss. All 37 patients with stage IIIA(N2) were treated with platinum-based induction chemotherapy followed by surgery plus radiotherapy if no progression was observed. The other 33 patients with stage IIIB were treated with platinum-based induction chemotherapy followed by conventional fractionation radiotherapy if no progression was observed. The overall response rate to induction chemotherapy was 40%. Median survival of the 70 patients was 13 months, with a 4-year survival of 15%. At univariate analysis, two prognostic factors correlated with survival: partial or complete response to induction chemotherapy (P<0.00001) and bulky mediastinal lymph nodes (N2>2.5 cm) (P=0.03). At multivariate analysis, only the response to induction chemotherapy retained statistical significance (P=0.00001). Randomized well-balanced prospective trials considering initially mediastinal N2 node size are needed to clearly establish the role of chemotherapy, surgery and radiotherapy in LA-NSCLC.

Adult↗

Preoperative high-dose cisplatin versus moderate-dose cisplatin combined with ifosfamide and mitomycin in stage IIIA (N2) non small-cell lung cancer: results of a randomized multicenter trial.

Preoperative chemotherapy has become an accepted treatment for stage IIIA (N2) non small-cell lung cancer (NSCLC). The majority of induction regimens employ cisplatin, although the importance of cis-platin dose in combination is unclear. A randomized trial was conducted to address whether higher pre-operative cisplatin doses result in improved survival and increased pathologic complete response in NSCLC. Patients with stage IIIA clinically enlarged and biopsy-proven N2 lesions were randomly assigned to receive either high-dose cisplatin (HDCP) (100 mg/m2) or moderate-dose cisplatin (MDCP) (50 mg/ m2) in combination with ifosfamide (3 g/m2) and mitomycin (6 mg/m2). Disease was restaged after 3 cycles, and those patients with response or stable disease underwent thoracotomy. From March 1993 to February 1997, 83 patients were randomized: 46 received HDCP, and 37 received MDCP. Clinical characteristics were well matched. Radiographic response rate was 59% for HDCP patients and 30% for MDCP patients (P = 0.01). Thoracotomy was performed in 71 patients (86%), 58 of whom had resectable disease. Complete resection rate was 61% in the HDCP group, and 51% in the MDCP group (P = 0.5). Postoperative mortality was 11%. Pathologic complete response was observed in one patient who received MDCP. Median survival in the HDCP and MDCP groups was 13 and 11 months, respectively (P = 0.3). In conclusion, higher radiographic response rate is observed in patients who receive HDCP, but this study fails to show any significant improvement in either overall survival or pathologic complete response in this group of patients.

Clinical Trial↗

[Why evidence-based medicine? 20 years of meta-analysis].

BACKGROUND: Meta-analysis, described within evidence-based medicine, has become a frequent issue in recent medical literature. An exhaustive search of reported meta-analysis from any medical specialty is described. MATERIAL AND METHODS: Search of papers included in Medline or Embase between 1973-1998. A study of intra and inter-reviewers liability about selection and classification have been performed. A descriptive analysis of the reported papers (frequency tables and graphics) is described, including differences of mean of reported meta-analysis papers by medical specialty and year. RESULTS: 1,518 papers were selected and classified. Most frequently found (45.91%) were: methodology (15.7%), psychiatry (11.79%), cardiology (10.01%) and oncology (8.36%). Inter personal agreement was 0.93 in selecting papers and 0.72 in classifying them. Between 1977-1987 overall mean of reported studies of meta-analysis (1.67 + 4.10) was significatively inferior to the 1988-1998 (49.54 + 56.55) (p < 0.001). Global number of meta-analysis was positively correlated (p < 0.05) with the number of studies about fundamentals and methodology during the study period. CONCLUSIONS: The method used to identify meta-analysis reports can be considered to be adequate; however, the agreement in classifying them in medical specialties was inferior. A progressive increase in the number of reported meta-analysis since 1977 can be demonstrated. Specialties with a greater number of meta-analysis published in the literature were: psychiatry, oncology and cardiology. Diffusion of knowledge about fundamentals and methodology of meta-analysis seems to have drawn and increase in performing and reporting this kind of analysis.

Evidence-Based Medicine↗

Randomized phase III study of gemcitabine-cisplatin versus etoposide-cisplatin in the treatment of locally advanced or metastatic non-small-cell lung cancer.

PURPOSE: We conducted a randomized trial to compare gemcitabine-cisplatin with etoposide-cisplatin in the treatment of patients with advanced non-small-cell lung cancer (NSCLC). The primary end point of the comparison was response rate. PATIENTS AND METHODS: A total of 135 chemotherapy-naive patients with advanced NSCLC were randomized to receive either gemcitabine 1,250 mg/m2 intravenously (IV) days 1 and 8 or etoposide 100 mg/m2 IV days 1 to 3 along with cisplatin 100 mg/m2 IV day 1. Both treatments were administered in 21-day cycles. One hundred thirty-three patients were included in the intent-to-treat analysis of response. RESULTS: The response rate (externally validated) for patients given gemcitabine-cisplatin was superior to that for patients given etoposide-cisplatin (40.6% v 21.9%; P = .02). This superior response rate was associated with a significant delay in time to disease progression (6.9 months v 4.3 months; P = .01) without an impairment in quality of life (QOL). There was no statistically significant difference in survival time between both arms (8.7 months for gemcitabine-cisplatin v 7.2 months for etoposide-cisplatin; P = .18). The overall toxicity profile for both combinations of drugs was similar. Nausea and vomiting were reported more frequently in the gemcitabine arm than in the etoposide arm. However, the difference was not significant. Gemcitabine-cisplatin produced less grade 3 alopecia (13% v 51%) and less grade 4 neutropenia (28% v 56% ) but more grade 3 and 4 thrombocytopenia (56% v 13%) than did etoposide-cisplatin. However, there were no thrombocytopenia-related complications in the gemcitabine arm. CONCLUSION: Compared with etoposide-cisplatin, gemcitabine-cisplatin provides a significantly higher response rate and a delay in disease progression without impairing QOL in patients with advanced NSCLC.

Adult↗

Phase II trial assessing the combination of gemcitabine and cisplatin in advanced non-small cell lung cancer (NSCLC).

BACKGROUND: There is need for more active and better tolerated combinations in non-small cell lung cancer (NSCLC). The Spanish Lung Cancer Group (SLCG) therefore conducted this phase II study to define the efficacy and toxicity profile of the combination of higher doses than usual of gemcitabine along with cisplatin in patients with advanced NSCLC. PATIENTS AND METHODS: Forty patients with pathologically documented advanced NSCLC were included in this trial (34 men, six women; aged 34-74 years; mean 64 years). Twenty-two patients had unresectable stage IIIB disease and 18 had stage IV disease. Karnofsky performance status was > or =70%. In five patients, surgery had previously been performed and four patients had received radiotherapy. Gemcitabine at a dose of 1200 mg/m2 was administered weekly (days 1, 8 and 15) and cisplatin 100 mg/m2 on day 15 of each 28-day cycle. RESULTS: Responses were scored according to standard World Health Organization criteria. Of 40 assessable patients, 19 had a partial response for an overall response rate of 47.5% (95% confidence interval (CI) 32-64%). To date, median survival for the whole group is 10.4 months (95% CI 6.2-11.7 months), with a 1-year survival rate of 35%. Toxicity was mainly haematological. Seven patients (18%) had grade 4 neutropenia (one episode of febrile neutropenia). Thrombocytopenia (12.8% grade 3 and 2.6% grade 4) was not associated with clinical bleeding. One patient had a grade 4 transient rise in transaminase. There was no grade 3 or 4 renal toxicity. There was no grade 4 symptomatic toxicity. The most common grade 3 toxicities were nausea and vomiting (28.2%) and alopecia (10.3%) both related to cisplatin. CONCLUSIONS: Gemcitabine can be safely administered at a dose of 1200 mg/m2 in combination with cisplatin. Thrombocytopenia seems to be less than in schedules with cisplatin given on day 1. The results of this studyshow promising activity (47.5% response rate) with modest toxicity. As this combination of gemcitabine and cisplatin deserves further evaluation in prospective randomized trials, the SLCG is comparing gemcitabine-cisplatin with etoposide-cisplatin in a phase III randomized study.

Adult↗

[Evaluation of intravenous ranitidine and omeprazole effect on the 24-hour gastric ph-metry in duodenal ulcer hemorrhage].

BACKGROUND: The pharmacotherapy of bleeding peptic ulcer is directed to improve the environment of the bleeding point by keeping the gastric pH above the proteolytic range for pepsin. OBJECTIVE: To evaluate the best pharmacological approach to inhibit gastric acid secretion with current antisecretory drugs in patients with bleeding duodenal ulcers. METHODS: Forty-seven patients with bleeding duodenal ulcers were randomized to receive I.V.: I) Omeprazole: an initial bolus of 80 mg + perfusion of 3.3 mg/h; II) Omeprazole: an initial bolus of 80 mg + 40 mg/12 h; III) Omeprazole: 40 mg/8 h; IV) Ranitidine: perfusion of 12.5 mg/h; V) Ranitidine: 50 mg/4 h. Gastric acidity was measured and recorded by 24 h gastric pH monitoring. RESULTS: All types of treatment with omeprazole were superior to either continuous perfusion or intermittent bolus of ranitidine in increasing the pH for 24 h and reducing the % of time the gastric pH was below 4 and 6, and the number of time the gastric pH was below 4 for more than 5 min. There were no statistical differences between the different regimens of omeprazole, but continuous perfusion of ranitidine was superior to intermittent ranitidine bolus. CONCLUSIONS: Parenteral omeprazole is better than parenteral ranitidine in keeping the intragastric pH above the proteolytic range for pepsin in patients with bleeding duodenal ulcers.

Adolescent↗

Effect of parenteral omeprazole and ranitidine on gastric pH and the outcome of bleeding peptic ulcer.

The pharmacotherapy of bleeding peptic ulcer is directed at attempting to keep the gastric pH above the proteolytic range for pepsin. In this randomized, prospective, open clinical trial we have compared the effects and outcome of omeprazole versus ranitidine in patients with bleeding peptic ulcer. Of 219 consecutive patients with upper gastrointestinal bleeding, 51 (23.2%) had an ulcer with endoscopic predictors of rebleeding at the time of diagnosis. These 51 patients were selected at random to receive either omeprazole (80 mg bolus and 40 mg/12 h i.v.) or ranitidine (50 mg/4 h i.v.). No endoscopic therapy was performed at the time of diagnosis. Twenty of these patients with duodenal ulcer (n = 10 omeprazole, n = 10 ranitidine) underwent 24-h gastric pH monitoring. Both groups were homogeneous in all clinical and endoscopic parameters. No differences in blood transfusion units, time of hospitalization, the lowest hematocrit measured, and mortality rates were observed between the groups. However, omeprazole reduced the number of rebleeding episodes (p = 0.1) and the need for surgery (3.8% vs. 22.7%; p = 0.05). Omeprazole also reduced the amount of time the gastric pH was < 6 (15.3 +/- 5.9% vs. 61.8 +/- 5.6%, p < 0.0001). We conclude that parenteral omeprazole is much more effective than ranitidine in keeping the gastric pH above the proteolytic range for pepsin in bleeders and that this might explain a better outcome in a subset of patients with bleeding peptic ulcers treated with parenteral omeprazole.

Adult↗

[Favorable response to cisapride in acute colonic pseudo-obstruction (Ogilvie's syndrome)].

Acute pseudobstruction of the colon (Ogilvie's syndrome) has been treated by different surgical, endoscopic and radiological procedures, but a high proportion of recurrences has been reported. Here, we report two cases that showed a fast and favorable response to oral cisapride, a prokinetic agent that may become the treatment of choice for these patients.

Acute Disease↗

Randomized phase II trial comparing two chemotherapy combinations for non-small cell lung cancer. Mitomycin, ifosfamide, and cisplatin versus vindesine, ifosfamide, and cisplatin.

Two chemotherapy regimens for advanced NSCLC given on an outpatient basis were evaluated in a prospective phase II trial: mitomycin, ifosfamide, and cisplatin (MIP) vs vindesine, ifosfamide, and cisplatin (VIP). This study included 100 patients. Prognostic factors were well balanced between the arms. Objective response rates (CR: MIP 0%, VIP 4%; PR: MIP 24%, VIP 18%) and survival (median time: 7 months in both arms) were in the standard range usually reported. Subjective and symptomatic improvement have been assessed. Toxicity was moderate, manageable, and mostly reversible. We believe that investigation for new ambulatory schemes must continue.

Adult↗

Protective effect of triflusal against acute myocardial infarction in patients with unstable angina: results of a Spanish multicenter trial. Grupo de Estudio del Triflusal en la Angina Inestable.

A multicenter, double-blind, placebo-controlled study was carried out to evaluate the effect of a new antiplatelet agent, triflusal (2-acetoxy-4-trifluoromethyl benzoic acid), in the prevention of nonfatal myocardial infarction and cardiac or vascular death (principal end-points) in patients with unstable angina. 281 patients were randomly assigned to triflusal (300 mg t.i.d.; n = 143) or placebo (n = 138). After 6 months of treatment, the incidence of nonfatal acute myocardial infarction was significantly lower in the triflusal than in the placebo group: 6 patients (4.2%) versus 17 (12.3%), p = 0.013. The low number of deaths (2/143 triflusal versus 0/138 placebo recipients) hampered statistical analysis of mortality rates. The need for revascularization was similar in the two groups: 24 patients (16.8%) in the triflusal group and 28 (20.3%) in the placebo group, p = 0.449. In conclusion, the results show that treatment with triflusal can reduce the incidence of myocardial infarction in patients with unstable angina.

Administration, Oral↗

[Pulmonary small cell carcinoma: late sequelae in long-term survivors].

BACKGROUND: To assess the long term survivors rate and its complications in a group of patients diagnosed of small cell lung cancer. METHODS: Clinical records of 227 patients diagnosed of small cell lung cancer over a period of ten years have been retrospectively reviewed. Global survival, survival free of disease, type of therapy, and complications developed after the initial diagnosis have been analyzed in patients surviving two or more years after the initial diagnosis of small cell lung cancer. RESULTS: Global survival has been of 7% at two years and 2% at five years. Three patients (19%) reached the two years survival with active disease. Other three patients developed late relapses after a minimum follow up of two years free of disease. 19% of survivors suffered a second neoplasm. 31% developed signs and symptoms of lung fibrosis. A patient (6%) developed ischemic cardiopathy and another one presented a neurologic picture consisting in progressive neurologic changes and dementia that could not be attributed to his initial disease. CONCLUSIONS: Long term survival in small cell lung cancer is still a relatively rare event however the potential complications for these patients are significant. Balance between benefit of therapy and its toxicity must be optimized.

Adult↗

Non-small-cell lung cancer (NSCLC): chemotherapy in advanced disease. Our experience in ten years.

This is a review of the therapeutic schedules used in our service during the past 10 years for the therapy of advanced non-small-cell lung cancer. During the first years, nonrandomized trials were conducted and several combinations were tested: MACC (methotrexate, doxorubicin, cyclophosphamide, and CCNU), cisplatin-etoposide, and cisplatin-vindesine. The results of these trials were invariably discouraging: objective responses hardly reached 30%, while the survival was around 15 months in the best case. On December 1985 a new randomized trial, based on the combination MIP (mytomicin, ifosfamide, cisplatin) was designed; 60.7% of objective responses were achieved, with 9 complete remissions (17.6%) and 22 partial remissions (43.1%). Median survival was 15 months. In order to reduce the toxicity of this combination, carboplatin was substituted for cisplatin. Unfortunately, results were very poor. No complete remission, and only 5 partial responses (20%) were achieved. At the present time, a new randomized trial is being conducted. In it, MIP combination is compared with VIP (vindesine, ifosfamide, cisplatin). Preliminary results have shown no differences between both arms in response, toxicity, or survival. New therapeutic approaches, as neoadjuvant therapy, are being explored.

Antineoplastic Combined Chemotherapy Protocols↗