A phase II study of weekly carboplatin and paclitaxel as first-line treatment of elderly patients with advanced ovarian cancer. A Multicentre Italian Trial in Ovarian cancer (MITO-5) study

BACKGROUND: Carboplatin/paclitaxel every 3 weeks is the standard for patients with ovarian cancer, but elderly patients frequently receive modified schedules or single agent chemotherapy to avoid toxicity. A phase II study was conducted to describe tolerability of a weekly schedule of both drugs in elderly patients. METHODS: Patients aged>or=70 years with stage IC-IV ovarian cancer, performance status相似文献   

Combination chemotherapy with carboplatin and docetaxel for elderly patients with non-small-cell lung cancer

The efficacy and toxicity of treatment with carboplatin (AUC= 5)+ docetaxel (70mg/m2) were analyzed retrospectively in 27 elderly patients with advanced non-small-cell lung cancer (NSCLC) aged 70 years or more. The median age of the patients was 74 years (range, 70-83 years). The performance status (ECOG), clinical stage, and tumor histology in the patients were as follows: PS: PS 0, 12 patients; PS 1, 11 patients; PS 2, 4 patients; disease stage: stage IIIA, 5 patients; stage IIIB, 11 patients; stage IV, 11 patients; tumor histology: adenocarcinoma, 18 patients; squamous cell carcinoma, 9 patients. The median number of treatment cycles administered was 4. The median survival time was 11.1 months and the 1-year survival rate was 40.7%. The response rate was 33.3%. The major toxicities were leukopenia and neutropenia; grade 3/4 neutropenia occurred in 22 patients (81.5%). Nonhematologic toxicities were generally mild, including grade 3 anorexia in 13 patients (48.1%) and grade 3 febrile neutropenia in 9 patients (33.3%). No treatment-related deaths were observed. Thus, it was concluded that the combination of carboplatin + docetaxel is a feasible, well-tolerated, and effective regimen for fit elderly patients with NSCLC. Prospective studies comparing carboplatin + docetaxel with third-generation single-agent chemotherapy or non-platinum-based combination chemotherapy are needed to confirm the efficacy and safety of this drug combination.     

以铂类为基础的两药联合方案治疗老年晚期非小细胞肺癌临床研究

目的 评价老年晚期非小细胞肺癌(NSCLC)患者接受以铂类为基础的两药联合化疗的疗效和安全性. 方法 对我院41例年龄≥70岁的老年晚期NSCLC患者应用以铂类为基础的两药联合方案化疗的情况进行了回顾性分析. 结果 41例患者中采用长春瑞滨方案的18例(43.9%),吉西他滨方案的9例(22.0%)、紫杉醇和多西紫杉醇方案各7例(17.1%).全组总有效率为19.5%,中位疾病进展时间和中位生存期分别为5.8个月和14.2个月,1年生存率为65.8%.化疗的主要不良反应为骨髓抑制,主要以白细胞和血小板减低为主,给予对症处理后可以恢复.患者无化疗相关死亡发生,有3例患者因出现Ⅲ～Ⅳ度骨髓抑制仪化疗1个周期. 结论 以铂类为基础的联合化疗方案治疗一般状况较好的老年晚期NSCLC疗效确切且耐受性较好.     

紫杉醇联合顺铂不同给药剂量治疗老年晚期非小细胞肺癌的临床分析

目的本研究旨在比较不同剂量紫杉醇联合卡铂治疗老年晚期非小细胞肺癌(NSCLC)患者的毒副反应及疗效。方法 62例老年晚期NSCLC患者被分为结果低剂量和常规剂量两组,根据体表面积,前者给予70 mg/m2和20 mg/m2,第1、8天静滴3小时。后者给予90 mg/m2和25 mg/m2,第1、8天静滴3小时。21天为一周期,随访疗效和毒副作用。结果低剂量组和常规剂量组的总体有效率分别为45.5%与47.5%,差异没有统计学意义(P>0.05),常见的不良反应有骨髓移植、恶性呕吐、脱发等,其他不良反应,均可耐受。结论低剂量紫杉联合顺铂治疗老年晚期NSCLC疗效较好,毒副作用可以耐受,值得临床推广应用。     

Second Line Therapy with Weekly Low-dose Docetaxel for Pretreated Non-Small-Cell Lung Carcinoma Patients: A Multicenter Italian Phase II Study

Docetaxel is one of the most active drugs in second-line therapy for non-small-cell-lung-carcinoma (NSCLC). The aim of this multicenter study was to evaluate the safety and efficacy of weekly low-dose docetaxel. Forty-two patients with advanced NSCLC pretreated with cisplatinum-based chemotherapy were enrolled. Docetaxel was administered at a dose of 25 mg/m² weekly for 12 consecutive weeks. A total of 386 doses were given with a median number of 10 doses per patient (range: 3–12). Treatment showed low incidence of hematologic toxicity and modest non-hematologic toxicity. An episode of grade 4 thrombocytopenia was reported but no episodes of grade 3 or 4 neutropenia. Most frequent non-hematologic toxicities were asthenia and alopecia. Response rate was 10.5% and median survival time (MST) was 12.8 weeks. Weekly treatment with 25 mg/m² docetaxel for 12 consecutive weeks appears to be a feasible and active regimen with mild toxicity in heavily pretreated NSCLC patients.     

Chemo-radiotherapy for stage III unresectable non-small cell lung cancer long-term results of a prospective study

INTRODUCTION: Combined-modality treatment is considered standard of care in the treatment of stage III non-small-cell lung cancer (NSCLC). This study was designed to assess the efficacy and tolerability of induction paclitaxel/carboplatin followed by concurrent thoracic radiotherapy and weekly paclitaxel. MATERIALS AND METHODS: Patients with unresectable stage III NSCLC were treated prospectively with two cycles of paclitaxel (175 mg/m2) and carboplatin (area under the curve of 6) followed by radiotherapy (60-66 Gy) concurrent with 6 weekly doses of paclitaxel (60 mg/m2). Response was determined 8 weeks after the completion of treatment and treatment-related toxicities were assessed at each visit during treatment and follow-up. RESULTS: Sixty-three patients were treated, 5 had complete response and 33 had partial response, giving a response rate of 60%. Thirty-seven percent of patients developed grade 3 or 4 neutropenia; 48% had significant esophagitis requiring the use of narcotic analgesics. Two patients developed esophageal stricture subsequently. The median survival was 51 months and 12 months for stage IIIA and IIIB patients, respectively. Progression-free survival was 16 months and 11 months respectively. CONCLUSIONS: The response rate was encouraging. Esophagitis was a significant morbidity and should prompt modification of treatment regimen, either in the chemotherapy schedule or by adjusting the radiotherapy treatment planning.     

Subcutaneous bortezomib in newly diagnosed patients with multiple myeloma nontransplant eligible: Retrospective evaluation

Bortezomib-melphalan-prednisone combination is one of the standards of care for nontransplant eligible patients with newly diagnosed multiple myeloma. However, bortezomib intravenous (twice weekly for 4 cycles then weekly for 5 cycles) results in ~13% of patients with grade 3-4 peripheral neuropathy. Bortezomib subcutaneous (SQ) and weekly delivery, improves tolerability without impairment of efficacy. The aim of this study was to evaluate the safety and effectiveness of SQ bortezomib-based combinations in nontransplant eligible patients with newly diagnosed myeloma in a real-world setting. A total of 135 patients (median age [range] = 76 [58-89], International Staging System-III = 54%, median follow-up = 14.8 months [1-40], Intensive group [twice weekly bortezomib] = 65%, Optimized group [weekly bortezomib] = 35%) were included and evaluable for safety, whereas 121 were evaluable for effectiveness. Overall response rate (95% CI) was 61% (53%, 71%) (complete response = 27%, very good partial response = 13%, and partial response = 21%) and median progression-free survival was 22.2 months (95% CI: 16.1-not reached). The 3-year overall survival was 75%. The most frequent grade 3-4 adverse events were thrombocytopenia (18%), neutropenia (17%), and anemia (11%). Peripheral neuropathy of any grade was observed in 44% of patients (2% with grade 3). Comparison between regimens (Intensive vs Optimized) showed similar overall response rate (57% vs 70%) and PFS (25 vs 19 months). A similar safety profile was observed between regimens. Thus, SQ bortezomib showed similar effectiveness and better tolerability as compared with results from intravenous bortezomib studies, and showing no differences either in effectiveness or safety in different bortezomib-based combinations.     

Gemcitabine Plus Paclitaxel Versus Carboplatin Plus Either Gemcitabine or Paclitaxel in Advanced Non-small-cell Lung Cancer: A Literature-based Meta-analysis

The combination of gemcitabine plus paclitaxel has been proposed as an alternative to the platinum-based combinations for treatment of advanced non-small-cell lung cancer (NSCLC). However, conflicting results have been reported. This meta-analysis was performed to compare the activity, efficacy, and toxicity of gemcitabine plus paclitaxel versus carboplatin plus either gemcitabine or paclitaxel in patients with untreated advanced NSCLC. Randomized phase II and phase III clinical trials comparing gemcitabine plus paclitaxel with carboplatin plus gemcitabine or paclitaxel were collected from electronic databases (Medline, EMBASE, and the Cochrane Central Register of Controlled Trials), relevant reference lists, and abstract books. The published languages and years were not limited. Pooled odds ratios (ORs) were calculated for the 1-year survival rate (1-year SR), the overall response rate (ORR), and grade 3 and grade 4 toxicities. Four randomized controlled trials (2186 patients) were identified from 2051 reports. They were all published as full-text articles. No significant heterogeneity was detected in these studies. A significant difference in ORR favoring gemcitabine plus paclitaxel over carboplatin-based doublets was observed [OR = 1.20; 95% confidence interval (95% CI) = 1.02–1.42; P = 0.03], whereas the trend toward an improved 1-year SR was not significant (OR = 1.07; 95% CI = 0.91–1.26; P = 0.41). An increased risk of grade 3–4 toxicities for patients receiving carboplatin-based chemotherapy was statistically demonstrated. The gemcitabine plus paclitaxel combination showed an improved ORR and a better toxicity profile but a similar 1-year SR compared to carboplatin-based doublets. For nonplatinum-based chemotherapy, gemcitabine plus paclitaxel is a useful alternative.     

NSCLC对小剂量紫杉醇同步放化疗的观察

目的观察小剂量紫杉醇配合同步放疗对局部晚期非小细胞肺癌（NSCLC）的疗效和毒副反应。方法 88例Ⅲ期NSCLC患者随机分为两组：A组（小剂量紫杉醇配合同步放疗）45例,同步放化疗中放疗采用三维适形放疗技术,DT60～66Gy/30～33f/6～7w。化疗使用小剂量紫杉醇方案,紫杉醇45mg/m^2qw（放疗期间）;B组43例,放疗方式同A组,化疗使用EP方案,依托泊苷50mg/m^2d1-5,d29-33;顺铂50mg/m^2d1、8、29、36。治疗完成后评价疗效和不良反应。结果 A组总有效率（CR＋PR）75.6%;1、2、3年生存率分别为48.9%,31.1%,22.2%;中位生存时间18.8个月。B组总有效率76.7%;1、2、3年生存率分别为51.7%,30.2%,21%,中位生存时间19.2个月。两组间总有效率和生存率均无显著统计学差异（P〉0.05）。毒副反应主要是放射性肺炎、放射性食管炎和骨髓抑制,两组间有显著统计学差异（P〈0.05）。结论小剂量紫杉醇同步放化疗与EP方案同步放化疗疗效相当,并有降低毒副作用的优点,值得临床推广。     

Multicenter cooperative observational study of idiopathic pulmonary fibrosis with non-small cell lung cancer

AIM: To research the natural course of idiopathic pulmonary fibrosis (IPF) with advanced non-small cell lung cancer (NSCLC) and the association between acute exacerbation (AE) of IPF and chemotherapy (CT). METHODS: From May 2007 through April 2011, 17 CT naive patients with IPF and advanced NSCLC were enrolled. Patients were classified into best supportive care (BSC) group or CT group based on the patient’s preference. Patients in the CT group received carboplatin (CBDCA) (AUC 5-6) plus paclitaxel (PTX) (175-200 mg/m²) on day 1 of each 21-d cycle as first-line therapy. RESULTS: All patients but one chose the CT group. In the CT group, the objective response rate was 38%. The most frequent toxicity ≥ grade 3 was neutropenia (88%). Two patients (12.5%) developed AE-IPF. The median progression-free survival, the median survival time and the 1-year survival rate were 4.1 mo, 8.7 mo and 35%, respectively. Second-line CT-related AE and CT-unrelated AE occurred in 2 and 3 patients (1: BSC group; 2: CT group), respectively. Seven (41%) of all patients developed AE-IPF throughout the clinical course, and 6 of 7 patients with AE-IPF died within one month. CONCLUSION: The incidence of AE-IPF was higher among IPF patients with advanced NSCLC than among those without NSCLC. CBDCA plus PTX regimen was tolerable and effective. However, AE-IPF has a fatal toxicity with or without CT in IPF patients with advanced NSCLC.     

A single institutional experience with central lung stereotactic body radiation therapy demonstrating encouraging results with increased inter-fraction time

BackgroundStereotactic body radiation therapy (SBRT) is an effective treatment modality for non-small cell lung cancer (NSCLC); however, there are concerns regarding potential toxicity for centrally located tumors.MethodsThis retrospective study considered patients with SBRT for central lung NSCLC (defined as a tumor within 2 cm of any mediastinal critical structure). The institutional protocol was that patients with central tumors received SBRT less frequently than daily—generally once or twice weekly.ResultsA total of 115 patients with 148 lesions were treated with SBRT to a median 45 [5–60] Gy in 4 [1–5] fractions over a median 5.3 [0–18] days. Many patients treated with this method presented with advanced disease: 58 treatments involved nodal targets, and 42 had stage 3 disease. 52% of patients had chronic obstructive pulmonary disease (COPD), and only 49% had a biopsy, often due to concerns regarding other medical comorbidities. Rates of prior chemotherapy, thoracic surgery, and thoracic radiotherapy were 32%, 21%, and 49%, respectively. Via the Kaplan-Meier method, 2-year overall survival was 65%, and 2-year local control was 77%. Two-year local-progression free survival was 53%, and 2-year progression-survival was 48%. Treatments for stage 3 disease had an impressive 82% 2-year local control that was comparable to early stage treatments. Patients with stage 3 disease had a 2-year overall survival of 59%, which trended towards decreased overall survival compared to early stage patients. There were 13 grade 1 (9%) and 14 grade 2 (9%) toxicities. There were no reported grade ≥3 acute or late toxicities and only 3 cases of pneumonitis.ConclusionsOur series demonstrates encouraging local control with low rates of toxicity for central lung SBRT, including many stage 3 patients. This may be the result of the relatively large inter-fraction interval. This interval may allow for greater tumor effects (such as reoxygenation) and improved tolerance from normal tissues.     

Oxaliplatin-based chemotherapy in the treatment of elderly patients with metastatic colorectal cancer (CRC)

Elderly patients constitute a subpopulation with special clinical features that differ from those of the general population and are under-represented in clinical trials. We retrospectively analyzed the toxicity and efficacy of oxaliplatin-based chemotherapy in the treatment of elderly patients affected by metastatic (m) CRC. Seventy-five consecutive patients aged 65-75 years (median age 71 years), 51 males and 24 females, with mCRC and measurable disease, were analyzed. The primary site of metastases was the liver (38.6% of patients). The majority of patients had a performance status (PS) according to the Eastern Cooperative Oncology Group (ECOG) PS before treatment of 0-1 (96%). The overall response rate was 57.3%, median progression-free survival was 7 months and median overall survival was 27 months. The main hematological and extra-hematological toxicities (grade 3 or 4) were neutropenia (20.0%), and neurological toxicity or diarrhea (6.7%), respectively. No toxic death occurred. Oxaliplatin-based chemotherapy maintains its efficacy, and safety in elderly patients with mCRC and good PS. This regimen should be considered in the treatment of this particular setting of patients.     

Gemcitabine and vincristine: an effective outpatient regimen with low myelotoxicity for stage IV non-small cell lung cancer

The activity and tolerability of gemcitabine and the non-overlapping toxicity of gemcitabine plus vincristine were the basis for testing this regimen patients with non-small cell lung cancer (NSCLC). Forty patients (25 male/15 female, median age 52 years) with stage IV NSCLC and a Karnofsky Performance Status score > or = 60 entered the trial. Patients received gemcitabine 1000 mg/m2 on days 1, 8 and 15 and vincristine 1.4 mg/m2 on days 1 and 15, every 4 weeks. The overall response rate was 16/40 (40%) (N = 40); with 2 complete and 14 partial responses; additional 14 patients had minor responses or stable disease. Median duration of remission was 4.5 months, and the median survival was 9 months. In two patients with grade 2 generalized vesicular rash and severe malaise, respectively, treatment-related toxicity led to early termination of treatment. Among patients treated for more than two months, vincristine doses were reduced/omitted for 55% of cycles because of grade 1-2 peripheral neuropathy. Myelotoxicity was frequent but rarely clinically significant. Mean platelet counts on day 1 of cycles 2,3 and 4 were significantly higher than the pre-treatment or post-treatment values. We conclude that vincristine plus gemcitabine is an an active and well tolerated regimen. Its interesting "platelet-saving" effect deserves further investigation.     

紫杉醇联合卡铂治疗老年和中青年晚期非小细胞肺癌的研究

目的研究紫杉醇联合卡铂治疗老年和中青年晚期非小细胞肺癌患者的疗效、预后和毒副反应。方法对2002年1月~2005年12月我院收治的50例≥70岁的肺癌患者（老年组）和同一时间随机选择的50例〈70岁肺癌患者（中青年组）分别给予紫杉醇联合卡铂方案化疗。结果老年组有效率37.5%,中青年组有效率38.8%,差异无显著性（P〉0.05）。老年组中位生存时间为11.8个月,1年、2年生存率分别为31.3%、6.3%,中青年组中位生存期11.3个月,1年、2年生存率28.6%、4.1%,无显著性差异（P〉0.05）。主要毒副反应是骨髓抑制,Ⅲ及Ⅳ中性粒细胞减少老年组34.0%,中青年组30.0%,差异无显著性（P〉0.05）。结论年龄不是影响肺癌患者疗效、预后和毒副反应的主要因素。     

多西紫杉醇周疗联合小剂量顺铂治疗晚期非小细胞肺癌76例疗效观察

目的观察多西紫杉醇周疗联合小剂量顺铂治疗晚期非小细胞肺癌的疗效及毒副反应。方法对2005年7月至2007年10月哈尔滨医科大学附属第二医院经病理证实的76例非小细胞肺癌患者进行多西紫杉醇周疗 小剂量顺铂联合化疗。结果76例患者中部分缓解32例,稳定25例,进展19例,总有效率为42.1%。初治组有效率为46.3%,复治组有效率为37.1%。最常见的毒副反应为骨髓抑制,毒副反应均可耐受。结论多西紫杉醇周疗联合小剂量顺铂治疗非小细胞肺癌有较好的疗效,毒性反应小可以耐受,具有较好应用价值。     

An open multicenter phase II trial of docetaxel-gemcitabine in Charlson score and performance status (PS) selected elderly patients with stage IIIB pleura/IV non-small-cell lung cancer (NSCLC): the GFPC 02-02a study

The aim of this study was to determine the impact of patient selection based on age, comorbidity and performance status on the efficacy of platinum-free combination therapy on non-small-cell lung cancer after 65 years of age. We analyzed the overall response rate, the median survival time, the 1-year survival rate, toxicity and quality of life after one to three 6-week cycles of docetaxel 30mg/m(2) weekly and gemcitabine 900mg/m(2) at weeks 1, 2, 4 and 5. Fifty patients (median age 73.7 years) were eligible. The mean number of comorbid conditions per patient was 0.8 [Balducci L. Lung cancer and aging. ASCO 2005. Educational book. p. 587-91; Piquet J, Blanchon F, Grivaux M, et al. Primary bronchial carcinoma in elderly subjects in France. Rev Mal Respir 2003;20:691-9; Jatoi A, Hillman S, Stella P, et al. Should elderly non-small-cell lung cancer patients be offered elderly-specific trials? Results of a pooled analysis from the North Central Cancer Treatment Group. J Clin Oncol 2005;23:9113-9; Balducci L, Extermann M. Management of cancer in the older person: a practical approach. Oncologist 2000;5:224-37]. Forty-five patients were assessable: 17 (34%) had an objective response, 18 (36%) had stable disease and 10 progressed (20%). The median survival time was 7 months and the 1-year survival rate 23.5%. The main grade III-IV adverse event was neutropenia (32% of patients). CONCLUSION: Platinum-free dual-agent chemotherapy gives similar results in patients over 65, selected on the basis of their precise age and comorbidity, to that reported in younger subjects.     

Phase II study of uracil-tegafur plus cisplatin in patients with previously untreated advanced non-small cell lung cancer

Background and objective:   A multi-institutional phase II trial combining uracil-tegafur (UFT) and cisplatin (CDDP) was conducted in patients with previously untreated advanced non-small cell lung cancer (NSCLC) to evaluate the safety and efficacy of this combined treatment regimen.
Methods:   The entry criteria for this study were previously untreated NSCLC, measurable disease, age <80 years, performance status <2, and adequate haematological, hepatic and renal function. Patients were treated with 400 mg/m² oral UFT from day 1 to day 14 and 80 mg/m² cisplatin on day 15. The treatment course was repeated every 3 weeks.
Results:   Of the 68 patients enrolled, 64 (27 with stage IIIB and 37 with stage IV disease) were eligible for treatment. Twenty of the 64 patients responded to the chemotherapy (response rate 31.3%; 95% CI 21.2–43.4%). The median survival time was 8.6 months, and the 1-year survival was 41.5%. Haematological toxicity ≥WHO grade 3 was seen in 3 (4.7%) patients. For non-haematological toxicities, anorexia with WHO grade 3 was seen in 8 (12.5%) patients, nausea and vomiting with WHO grade 3 in 4 (6.3%), diarrhoea with WHO grade 4 in 1 (1.6%), and liver dysfunction with WHO grade 4 in 1 (1.6%) patient.
Conclusions:   The combination of oral UFT plus cisplatin was found to be a safe and active treatment against advanced NSCLC. The observed low toxicity of this combined regimen may warrant its application to the treatment of elderly patients.     

Phase II study of 3-hour infusion of high dose paclitaxel in refractory and relapsed aggressive non-Hodgkin's lymphomas. Groupe d'Etude des Lymphomes de l'Adulte

BACKGROUND AND OBJECTIVE: The first clinical studies of paclitaxel as a single agent for the treatment of relapsed or refractory low or intermediate grade non-Hodgkin's lymphomas (NHL) yielded controversial results regarding the response rates observed, mainly related to the dose and schedule of administration used. To obtain additional data concerning the efficacy and toxicity of paclitaxel in intermediate and high grade NHL we initiated a phase II study using a 3-hour infusion of high doses of paclitaxel. DESIGN AND METHODS: The eligibility criteria included patients with relapsed or refractory aggressive NHL, a performance status < or = 2 (WHO index), a platelet count > or = 100,000/microL, a neutrophil count > or = 2,000/microL, measurable disease, and adequate hepatic function. Patients were excluded if they were infected with HIV, had a left ventricular ejection fraction < 50%, or prior peripheral neuropathy. Paclitaxel was administered as a 3-hour infusion at a dose of 250 mg/m2 every 3 weeks for a maximum of 6 courses. RESULTS: Of 45 eligible patients, 42 received a total 73 courses of paclitaxel. Forty patients were assessable for response (89%), and 42 for toxicity (93%). Six patients (15%) achieved a partial (n = 4) or a complete remission (n = 2). Responses were observed in intermediate grade (n = 4) as well as in high grade lymphoma (n = 2). The main factor influencing the response to paclitaxel was the median duration of response to previous chemotherapy regimens which was 3 times longer in patients who responded to paclitaxel (16.3 months) than in patients who did not respond to paclitaxel (5.2 months) (p<0.05). The most common serious side effects were related to the hematologic toxicity of paclitaxel, and included grade IV granulocytopenia in 20 cases (48%), grade III/IV thrombocytopenia in 14 cases (33%) and grade III-IV anemia in 13 cases (31%). INTERPRETATION AND CONCLUSIONS: Despite frequent manageable hematologic toxicity, paclitaxel is usually well tolerated at a dose of 250 mg/m2 given by a 3-hour infusion. However, the clinical efficiency as a single therapy seems modest in relapsed or refractory aggressive lymphoma.     

Doxetaxel in previously treated non-small cell lung cancer patients: clinical efficacy and quality of life

Docetaxel (Taxotere) is one of the most active new generation chemotherapy agents against advanced non-small cell lung cancer (NSCLC). This study aimed to determine the activity, toxicity and impact on the quality of life (QOL) in patients treated with docetaxel after failure with first-line platinum-based combination chemotherapy. Twenty-one patients with advanced NSCLC who had previously received the platinum-containing regimen were treated with docetaxel 75 mg/m2 every 3 weeks. QOL was assessed at intervals during the treatment period using the Functional Assessment of Cancer Treatment - Lung (FACT-L). Of the 21 patients enrolled, 16 were able to be evaluated for response and 20 were included in the toxicity analysis. The median age was 57 (range, 39-75 years). A median of 3 cycles was given (range, 1-9). Of the 16 evaluatable patients, there was one partial response (6.3%) and 4 with stable disease (25%). The median survival time was 8.1 months and the 1-year survival rate was 25%. Myelosuppression and peripheral neuropathy were the major toxicities. Grade 3/4 neutropenia and paresthesia occurred in 6 patients (30%) and 3 patients (15%), respectively. There was no significant improvement or deterioration in the overall FACT-L, TOI (Trial Outcome Index) and lung cancer symptom scores during the treatment. Symptom improvement was noted, in particular for shortness of breath and weight loss in the majority of patients. It is concluded that docetaxel is a well tolerated second-line treatment for recurrent NSCLC. Of particular importance was that the treatment did not negatively impact the overall quality of life, on the contrary, did palliate some of the lung cancer related dash symptoms in many patients.     

A phase II study of thalidomide and vinblastine for palliative patients with Hodgkin's lymphoma

INTRODUCTION: Patients with Hodgkin's Lymphoma (HL) who relapse or progress after primary therapy and subsequent high dose chemotherapy with autologous stem cell transplantation (ASCT) cannot be cured with conventional treatment. We combined thalidomide (THAL), an agent with anti-angiogenic and immunomodulatory properties, with vinblastine, which is active after ASCT, to determine the objective response rate, improvement in B symptoms and toxicity in patients with refractory HD. METHODS: Patients were eligible if they HD that progressed after chemotherapy and ASCT or had declined or were ineligible for curative therapy. Treatment consisted of THAL 200 mg orally given daily. After 2 weeks, VBL 6 mg IV was given weekly x 6 doses on an eight-week cycle. Response and toxicity assessment occurred following each cycle. RESULTS: Eleven patients were enrolled, 1 progressed within 6 days of study enrollment and was subsequently treated with alternative palliative therapy and thus 11 patients are response evaluable and 10 are evaluable for toxicity. Patient characteristics: relapsed after ASCT: 7; median number of prior chemotherapy regimens: 3 (range 1-5); median time to progression post-ASCT: 7 months (range 2-29). Four patients had a partial response to treatment (response rate 36%); two patients had stable disease. B symptoms were present at enrollment in four patients and resolved completely on treatment in two patients. Five had disease progression within 3 months of starting treatment. The median duration of response was 9 months (range 0-22 months). Toxicity was mild and limited to grade 2 neuropathy in 6 patients and grade 2 or 3 neutropenia in 4 patients. CONCLUSIONS: In this small study in chemotherapy- refractory HL, THAL and VBL demonstrated encouraging activity with some durable responses and acceptable toxicity. These results suggest that chronic low dose chemotherapy combined with less toxic immunomodulatory or anti-angiogenic drugs warrants further study.