Induction chemotherapy with mitomycin, vindesine, and cisplatin for stage III unresectable non-small-cell lung cancer: results of the Toronto Phase II Trial.

PURPOSE: The 5-year survival rates with surgical resection for preoperatively identified stage IIIA N2 non-small-cell lung cancer (NSCLC) are less than 10%. A pilot study of mitomycin, vindesine, and cisplatin (MVP) induction chemotherapy was undertaken in an attempt to improve the curative potential of surgery in this group of patients. PATIENTS AND METHODS: Thirty-nine patients with mediastinoscopy stage IIIA N2 NSCLC received two cycles of MVP. Responding patients underwent thoracotomy for resection and two further courses of MVP. RESULTS: The overall response rate was 64% (25 of 39) with three complete and 22 partial responses. Twenty-two patients were resected, which included a radical mediastinal node dissection. Eighteen resections were complete and four were incomplete. Pathologically, three patients (7.7%) had no tumor remaining. Toxicity included two postoperative deaths secondary to a bronchopleural (BP) fistula, mitomycin pulmonary toxicity in two patients, and septic deaths in four patients. Twenty-eight patients have died; 20 have recurrent or progressive disease. Eight of the 18 patients completely resected have recurred, with a median time to recurrence of 20.6 months. Sites of recurrence include two locoregional, five distant (two in brain), and one in both. Median survival of all 39 patients is 18.6 months, with a 3-year survival of 26%. The median survival for those patients completely resected was 29.7 months with a 3-year survival of 40%. CONCLUSIONS: We conclude (1) that MVP is an effective but toxic chemotherapeutic regimen for limited NSCLC; (2) the median survival seems to be prolonged; and (3) the role of induction chemotherapy followed by surgery in stage IIIA N2 NSCLC requires a phase III randomized trial to compare it with other treatment modalities.     

新辅助化疗对围手术期非小细胞肺癌患者的影响

目的 研究新辅助化疗(MVP)是否影响非小细胞肺癌患者围手术期的安全性。方法 所有患者化疗方案均为MVP，即丝裂霉素(MMC) 长春碱胺(VDS) 顺铂(DDP)。将接受2周期术前新辅助化疗、根治性手术和2次术后化疗的患者与接受同样手术和4次术后化疗的患者进行比较。结果 在107例符合要求的病例中，新辅助化疗组有66例，对照组有41例，两组在性别、年龄、肿瘤分期、病理类型上均无统计学差异。新辅助化疗组患者的手术时间(P=0．262)、术中失血量(P=0．704)、术中输血量(P=0．811)、输血总量(P=0．074)比对照组患者略高，术后总引流量(P=0．061)稍低，但其差异均无统计学意义。两组术后死亡率(P=0．674)和并发症：心律失常(P=0．608)、支气管胸膜瘘(P=0．378)、肺炎(P=0．622)、呼吸衰竭(P=0．285)的比较亦均无统计学意义。结论 新辅助化疗对非小细胞肺癌患者围手术期的安全性无显著影响。     

Induction chemotherapy with mitomycin, vindesine, and cisplatin for stage IIIA (T1-3, N2) unresectable non-small-cell lung cancer: final results of the Toronto phase II trial

PURPOSE: This is a phase II study to assess the role of induction chemotherapy in the management of stage IIIA non-small-cell lung cancer (NSCLC). We are now reporting the long-term follow-up of the Toronto phase II trial. METHODS: Sixty five patients with mediastinoscopy proven stage IIIA NSCLC received two cycles of preoperative MVP or VLB/P followed by thoracotomy followed by two further courses of chemotherapy. RESULTS: The overall response rate was 67.7% with three complete and 41 partial responders. Forty seven patients went on to thoracotomy with 35 complete resections. Pathologically 4.6% of patients had no tumour remaining. There were three postop deaths as well as five chemotherapy related deaths. Of the 35 patients completely resected 19 have recurred including eight in brain. The median survival for the entire 65 patients is 18.6 months with a 1 year survival of 66%, 5 year survival of 29% and a 10 year survival of 22%. CONCLUSIONS: The long-term survival of induction chemotherapy is maintained. The high incidence of brain recurrences warrants assessment of the role of prophylactic cranial radiation. The role of surgery for stage IIIA NSCLC following induction chemotherapy awaits further study.     

Combined regional and systemic chemotherapy for advanced and inoperable non-small cell lung cancer.

AIMS: The objective was to establish the feasibility and toxicity of regional chemotherapy using an isolated thoracic perfusion (ITP) technique plus low dose systemic chemotherapy as induction chemotherapy followed by surgery in advanced non-small cell lung cancer (NSCLC). METHODS: twenty-two chemotherapy-naive patients with NSCLC (median age of 57 years, stage III-IV disease with metastases only in the thoracic region, Karnofsky index >60), received two cycles of regional plus systemic chemotherapy with a treatment-free interval of 4 weeks. The cytostatic regimen consisted of 10 mg/m(2) mitomycin, 25 mg/m(2) navelbine and 30 mg/m(2) cisplatin during ITP followed by low-dose systemic chemotherapy with 250 mg/m(2) 5-fluorouracil and 20 mg/m(2) cisplatin given as a continuous infusion on day 1-4. Patients were re-evaluated for response and surgery was carried out if possible. RESULTS: All 22 patients could be assessed for toxicity, response and survival. There were 19/22 remissions corresponding to a regression rate of 86.4%; 16/22 patients could be resected. This corresponded to a resectability rate of 72.7% (13 complete resections R0, 1 R1, 2 R2). Side-effects were transient and acceptable with no treatment- or surgery-related deaths. Median survival has not been reached after an observation time of 15 months. The estimated 1-year survival rate was 67.3%. CONCLUSIONS: Regional chemotherapy using an ITP application form is highly effective in advanced NSCLC stage III-IV leading to a high rate of resectability with an encouraging survival outcome. Copyright Harcourt Publishers Limited.     

Dose intensity chemotherapy in lung cancer]

Dose intensity (DI) is defined as the amount of drugs administered per unit time (mg/m2/wk). Recently this concept is thought to be one of the most important tactics to improve the chemotherapeutic results. In this article, we summarized the reports about the impact of dose intensity chemotherapy on various malignancies and the experimental results in animal models. As the application of this concept for the treatment of lung cancer, we conducted the following trials. For the patients with small-cell lung cancer (SCLC), weekly intensive chemotherapy employing cisplatin, oncovin, doxorubicin, and etoposide (CODE regimen) was performed. Fifteen (88%) of 17 patients responded to this regimen, including 5 (29%) complete responders. The median survival time for all patients was 45 weeks. For the patients with non-small cell lung cancer (NSCLC), short interval (3 weeks) MVP (mitomycin, vindesine, and cisplatin) therapy using with recombinant human granulocyte-colony stimulating factor (rhG-CSF) was performed. This study was aimed at improving the therapeutic result by reducing the cycle length of MVP regimen through the use of rG-CSF. Thirty-two out of 40 patients could receive two or more cycles of MVP regimen on schedule. These results in SCLC and NSCLC suggest that does intensity chemotherapy can improve the outcome for patients with these disease.     

Docetaxel-based induction therapy prior to radiotherapy with or without docetaxel for non-small-cell lung cancer

This trial aimed to assess the feasibility and tumour control of concurrent chemoradiotherapy or radiotherapy alone after docetaxel-based induction chemotherapy in locally advanced non-small-cell lung cancer (NSCLC). Patients with stage IIIA/IIIB NSCLC received two 21-day cycles of induction chemotherapy with docetaxel (85 mg m(-2), day 1) plus cisplatin (40 mg m(-2), days 1 and 2). Patients without disease progression on day 43 were randomised to radiotherapy (2 Gy for 5 days week(-1); total 60 Gy) alone or with docetaxel 20 mg m(-2) once weekly every 6 weeks. Of 108 patients who received induction chemotherapy, 104 were evaluable for response. After induction chemotherapy, the overall response rate (ORR) was 44%; 91 (88%) patients had no disease progression and 89 were subsequently randomised to local treatment. After randomised therapy, the ORR was 53% (chemoradiotherapy 58%; radiotherapy 48%). Median survival and time to progression were 14.9 and 7.8 months, respectively, for chemoradiotherapy and 14.0 and 7.5 months, respectively, for radiotherapy. The most common toxicities during induction chemotherapy and randomised therapy were grades 3-4 neutropenia and grade 3 lymphocytopenia, respectively. Docetaxel-cisplatin induction therapy followed by concurrent docetaxel and thoracic radiotherapy is a feasible treatment option, showing good clinical activity and tolerability, for locally advanced NSCLC.     

Induction chemotherapy employing dose-intense cisplatin with mitomycin and vinblastine (MVP400), followed by thoracic surgery or irradiation, for patients with stage III nonsmall cell lung carcinoma.

BACKGROUND: Cisplatin-based induction chemotherapy before surgery or irradiation has improved the survival of patients with Stage III nonsmall cell lung carcinoma (NSCLC). Encouraged by earlier results with preoperative MVP (cisplatin [120 mg/m(2) or 25 mg/m(2)/week], vinblastine, and mitomycin) for Stage IIIA patients with clinically apparent mediastinal (N2) disease, the authors conducted a Phase II trial of the safety and efficacy of induction MVP400 with the dose intensity of cisplatin doubled from 25 to 50 mg/m(2) per week. METHODS: From October 1992 to March 1996, 37 patients with Stage IIIA (26) or Stage IIIB (11) NSCLC began the MVP400 induction chemotherapy program. Four doses of cisplatin (100 mg/m(2)), 7 doses of vinblastine, and 2 doses of mitomycin were given over 9 weeks. Patients received either surgery or irradiation after induction treatment. RESULTS: Overall, the response rate was 65% (95% confidence interval, 49-81%) with a complete resection rate of 67%. The median survival was 17 months, with 66% of patients alive at 1 year. Complete resection and Stage IIIA involvement were favorable prognostic indicators for survival. No Stage IIIB patients underwent a complete resection. Myelosuppression was the most common side effect. There were no treatment-related deaths. CONCLUSIONS: Although high response and complete resection rates were again demonstrated, results with the MVP400 regimen were not improved over those achieved with MVP regimen tested earlier with Stage IIIA (N2) patients. The authors continue to recommend MVP as an induction chemotherapy regimen for clinical trials.     

Long-term survival in patients with synchronous, solitary brain metastasis from non-small-cell lung cancer treated with radiosurgery

PURPOSE: To report the outcome of patients with synchronous, solitary brain metastasis from non-small-cell lung cancer (NSCLC) treated with gamma knife stereotactic radiosurgery (GKSRS). PATIENTS AND METHODS: Forty-two patients diagnosed with synchronous, solitary brain metastasis from NSCLC were treated with GKSRS between 1993 and 2006. The median Karnofsky performance status (KPS) was 90. Patients had thoracic Stage I-III disease (American Joint Committee on Cancer 2002 guidelines). Definitive thoracic therapy was delivered to 26/42 (62%) patients; 9 patients underwent chemotherapy and radiation, 12 patients had surgical resection, and 5 patients underwent preoperative chemoradiation and surgical resection. RESULTS: The median overall survival (OS) was 18 months. The 1-, 2-, and 5-year actuarial OS rates were 71.3%, 34.1%, and 21%, respectively. For patients who underwent definitive thoracic therapy, the median OS was 26.4 months compared with 13.1 months for those who had nondefinitive therapy, and the 5-year actuarial OS was 34.6% vs. 0% (p < 0.0001). Median OS was significantly longer for patients with a KPS >or=90 vs. KPS < 90 (27.8 months vs. 13.1 months, p < 0.0001). The prognostic factors significant on multivariate analysis were definitive thoracic therapy (p = 0.020) and KPS (p = 0.001). CONCLUSIONS: This is one of the largest series of patients diagnosed with synchronous, solitary brain metastasis from NSCLC treated with GKSRS. Definitive thoracic therapy and KPS significantly impacted OS. The 5-year OS of 21% demonstrates the potential for long-term survival in patients treated with GKSRS; therefore, patients with good KPS should be considered for definitive thoracic therapy.     

84例ⅢA-N 2 期非小细胞肺癌术前新辅助临床治疗结果分析

目的:探讨新辅助结合手术切除治疗ⅢA-N 2 期非小细胞肺癌的临床疗效。方法:收集2008年1 月至2013年7 月上海交通大学附属胸科医院收治的术前明确单侧纵隔淋巴结（且淋巴结短径≥ 1 cm）转移（ⅢA-N 2 期）,经新辅助治疗后再手术的非小细胞肺癌（non-small celll ung cancer ,NSCLC ）91例患者。总结并分析经术前新辅助治疗的反应率以及患者的生存情况并分析影响预后的因素。结果:3 年和5 年总生存期（OS）分别为57.7% 和34.2%;3 年和5 年无病生存期（DFS）分别为37.9% 和30.5% 。在OS和DFS 方面,R 0 和R 1 组之间（P = 0.118;P = 0.369）、新辅助化疗和放化疗组之间（P = 0.771;P = 0.953）、临床反应和无反应组之间（P =0.865;P = 0.862）以及不同组织病理类型组之间（P = 0.685;P = 0.208）比较差异均无统计学意义。肺叶切除及术后病理性淋巴结降期的患者分别优于相应地扩大性切除（P = 0.023;P = 0.024）和未降期（P = 0.036;P = 0.025）的患者。单因素分析显示肺叶切除和术后病理性淋巴结降期为有利的预测因子。多因素分析显示,病理淋巴结降期为术后DFS 的有利预测因子;无吸烟史及肺叶切除为OS的有利预测因子。结论:术前新辅助治疗ⅢA-N 2 期NSCLC 是可行的,能有效地使肿瘤大小及淋巴结降期,预后较为满意;预测预后方面,术后病理性降期要比临床反应更有意义;可行根治性肺叶切除及有病理性淋巴结降期的患者预后更好。      

Switch maintenance therapy with docetaxel and bevacizumab after induction therapy with cisplatin,pemetrexed, and bevacizumab in advanced non-squamous non-small cell lung cancer: a phase II study

Switch maintenance therapy, using alternative agents that were not administered during induction chemotherapy, is a treatment option for advanced non-squamous non-small cell lung cancer (NSCLC). Bevacizumab is known to increase the efficacy of other chemotherapeutic agents; however, switch maintenance therapy with docetaxel and bevacizumab has not been adequately studied. The goal of this study was to evaluate the efficacy and safety of switch maintenance therapy with docetaxel and bevacizumab following induction therapy with cisplatin, pemetrexed, and bevacizumab. Chemotherapy-naïve non-squamous NSCLC patients received induction therapy of four cycles of cisplatin (75 mg/m²), pemetrexed (500 mg/m²), and bevacizumab (15 mg/kg). Patients who achieved disease control after induction therapy then received maintenance therapy with docetaxel (50 mg/m²) and bevacizumab (15 mg/kg) until disease progression or unacceptable toxicity. The primary endpoint was progression-free survival from enrollment. This study enrolled 49 NSCLC patients, among which 38 (77.6%) completed the four cycles of induction therapy and received maintenance therapy. The median progression-free survival from enrollment was 7.8 months (95% confidence interval: 4.7–11.0 months). The most common toxicities of grade 3 or higher were neutropenia (68.4%), leukopenia (50.0%), febrile neutropenia (31.8%), and hypertension. Switch maintenance therapy with docetaxel and bevacizumab following induction therapy with cisplatin, pemetrexed, and bevacizumab demonstrated modest efficacy and frequent hematologic toxicity in non-squamous NSCLC patients.     

Results of Trimodality Therapy in Patients With Stage IIIA (N2-Bulky) and Stage IIIB Non–Small-Cell Lung Cancer

BackgroundThe survival rates for stage IIIA and stage IIIB Non–Small-cell lung cancer (NSCLC) are extremely poor with single-treatment modalities such as radiation therapy or surgery. The purpose of this study is to assess tolerability, response, surgical resectability, and survival of chemotherapy followed by chemoradiation therapy, and then followed by surgery in patients with stage IIIA (N2-bulky) or stage IIIB NSCLC.Patients and MethodsForty-eight patients with stage IIIA (N2-bulky) or stage IIIB (T4 N1-2 M0) NSCLC received 2 cycles of chemotherapy with cisplatin, mitomycin, and vindesine, subsequent radiation therapy (45 Gy, twice-daily 1.5 Gy) with simultaneous low-dose cisplatin and vindesine, followed by surgery.ResultsForty-five patients completed induction chemoradiation therapy. Thirty-three patients (68.8%) had clinical response to induction treatment. Thirty-nine patients underwent a thoracotomy, with a complete resection rate of 62.5% (30/48). The pathologic response rate was 60% (27/45), with complete pathologic response of 8 patients. The median survival time for the total group of 48 patients was 23 months, with 3- and 5-year survival rates of 41.7% and 31.8%, respectively. Multivariate analysis showed that complete resection and pathologic response in surgical specimens were independent predictors of survival (P = .048 and P = .022).ConclusionPreoperative sequence of chemotherapy followed by concurrent chemoradiation therapy is an effective approach in patients with stage IIIA (N2-bulky) and IIIB (T4 N1-2 M0) NSCLC. The operation after induction chemoradiation therapy should be performed in carefully selected patients with surgically resectable diseases. The patients who achieved complete resection and with pathologic response of tumor can benefit from surgery following induction chemoradiation therapy.     

低分子肝素联合化疗治疗非小细胞肺癌的随机研究

目的:观察低分子肝素联合MVP方案治疗晚期非小细胞肺癌的短期疗效,毒副反应及对生存期的影响。方法:46例非小细胞肺癌随机分为两组,A组(治疗组)为MVP+肝素;B组(对照组)为单纯MVP。两组均接受MVP方案两周期。化疗方案:MMC 6 mg/m2,VDS 3 mg/m2×2,DDP 90 mg/m2。治疗组加用低分子肝素5 000u皮下注射,化疗前三天起,每日二次,共7天。结果:治疗组有效率56.5％(13/23),中位生存期12.1月(95％CI:8.52～14.64月),一年生存率52.2％。对照组有效率39.1％(9/23),中位生存期8.4月(95％CI:6.15-10.85月),一年生存率34.8％。治疗组中位生存期及一年生存率明显大于对照组(P<0.05)。主要毒副反应为Ⅱ-Ⅲ度血液毒性,消化道反应均为Ⅰ-Ⅱ度。两组间毒副反应比较无显著差异(P>0.05)。结论:低分子肝素联合MVP方案能提高NSCLC的化疗疗效,延长生存,不增加毒副反应。     

MVP、CAP和EP方案治疗非小细胞肺癌的疗效比较

目的：探讨和比较MVP、CAP、EP三种不同化疗方案治疗非小细胞肺癌的疗效和毒副作用。方法：104例经病理确诊为非小细胞肺癌患随机分为3组,分别接受MVP、CAP、EP化疗方案治疗,观察各组的临床疗效、毒副反应并进行X^2检验比较。结果：MVP、CAP和EP3个不同化疗方案组的有效率分别是37．1％（13／35）、34．3％（12／35）、20．1％（7／34）,各组间疗效相似（P＞0．05）。MVP脱发的发生率和程度较CAP和EP方案低（P＜0．05）,年老体弱患对MVP方案能耐受,未发现心脏毒性。结论：MVP化疗方案可与CAP与EP方案一样作为治疗非小细胞肺癌的临床一线方案应用。     

Pre-operative chemotherapy in early stage resectable non-small-cell lung cancer: a randomized feasibility study justifying a multicentre phase III trial

Surgical resection offers the best chance for cure for early stage non-small-cell lung cancer (NSCLC, stage I, II, IIIA), but the 5-year survival rates are only moderate, with systemic relapse being the major cause of death. Pre-operative (neo-adjuvant) chemotherapy has shown promise in small trials restricted to stage IIIA patients. We believe similar trials are now appropriate in all stages of operable lung cancer. A feasibility study was performed in 22 patients with early stage (IB, II, IIIA) resectable NSCLC; randomized to either three cycles of chemotherapy [mitomycin-C 8 mg m(-2), vinblastine 6 mg m(-2) and cisplatin 50 mg m(-2) (MVP)] followed by surgery (n = 11), or to surgery alone. Of 40 eligible patients, 22 agreed to participate (feasibility 55%) and all complied with the full treatment schedule. All symptomatic patients achieved either complete (50%) or partial (50%) relief of tumour-related symptoms with pre-operative chemotherapy. Fifty-five per cent achieved objective tumour response, and a further 27% minor tumour shrinkage; none had progressive disease. Partial pathological response was seen in 50%. No severe (WHO grade III-IV) toxicities occurred. No significant deterioration in quality of life was detected during chemotherapy. Pre-operative MVP chemotherapy is feasible in early stage NSCLC, and this study has now been initiated as a UK-wide Medical Research Council phase III trial.     

Multimodality treatment of non-small cell lung cancer: response to cisplatin, VP-16, and 5-FU chemotherapy and to surgery and radiation therapy

Twenty-one patients with unresectable non-small cell lung cancer (NSCLC), 11 with stage III M0, five with malignant pleural effusion, and five with a single resectable metastasis were treated with multimodality therapy. All received two to three cycles of preoperative chemotherapy with a new sequential combination of cisplatin (50 mg/m2 IV X 1) followed by 5-FU infusion (40 mg/m2/hr X 72) and etoposide (80 mg/m2/day X 3). Thirteen of 21 (62%) had a partial response, and three (14%) had a minor response to chemotherapy. Of the 19 who underwent surgical exploration, 17 were confirmed to have NSCLC. Ten patients with NSCLC and one with choriocarcinoma were rendered disease free by resection of the primary tumor and lymph nodes. Six received intra- and/or perioperative interstitial therapy with 125I and/or 192Ir. Another patient was treated with 32P. Postoperative external radiotherapy was administered in 15 patients, and adjuvant chemotherapy was administered in ten. This multimodality therapy was well tolerated, safe, and highly effective, resulting in excellent palliation even in patients with pleural effusion and metastasis. The most promising results were in unresectable stage III M0 with a partial response rate of 82% following neoadjuvant chemotherapy and a complete response rate of 73% after surgery. In this group, median survival has not yet been reached and will exceed 12 months.     

Nonsmall cell lung cancer presenting with synchronous solitary brain metastasis

BACKGROUND: Solitary brain metastases occur in about 50% of patients with brain metastases from nonsmall cell lung cancer (NSCLC). The standard of care is surgical resection of solitary brain metastases, or stereotactic radiosurgery (SRS) plus whole brain radiation therapy (WBRT). However, the optimal treatment for the primary site of newly diagnosed NSCLC with a solitary brain metastasis is not well defined. The goal was to distinguish which patients might benefit from aggressive treatment of their lung primary in patients whose solitary brain metastasis was treated with surgery or SRS. METHODS: The cases of 84 newly diagnosed NSCLC patients presenting with a solitary brain metastasis and treated from December 1993 through June 2004 were retrospectively reviewed at The University of Texas M. D. Anderson Cancer Center. All patients had undergone either craniotomy (n = 53) or SRS (n = 31) for management of the solitary brain metastasis. Forty-four patients received treatment of their primary lung cancer using thoracic radiation therapy (median dose 45 Gy; n = 8), chemotherapy (n = 23), or both (n = 13). RESULTS: The median Karnofsky performance status score was 80 (range, 60-100). Excluding the presence of the brain metastasis, 12 patients had AJCC Stage I primary cancer, 27 had Stage II disease, and 45 had Stage III disease. The median follow-up was 9.7 months (range, 1-86 months). The 1-, 2-, 3-, and 5-year overall survival rates from time of lung cancer diagnosis were 49.8%, 16.3%, 12.7%, and 7.6%, respectively. The median survival times for patients by thoracic stage (I, II, and III) were 25.6, 9.5, and 9.9 months, respectively (P = .006). CONCLUSIONS: By applying American Joint Committee on Cancer staging to only the primary site, the thoracic Stage I patients in our study with solitary brain metastases had a more favorable outcome than would be expected and was comparable to Stage I NSCLC without brain metastases. Aggressive treatment to the lung may be justified for newly diagnosed thoracic Stage I NSCLC patients with a solitary brain metastasis, but not for locally advanced NSCLC patients with a solitary brain metastasis.     

Symptom relief with MVP (mitomycin C, vinblastine and cisplatin) chemotherapy in advanced non-small-cell lung cancer.

The role of chemotherapy in the palliation of patients with advanced stage (IIIB and IV non-small-cell lung cancer (NSCLC) remains controversial. We have carried out a chemotherapy study emphasising symptom relief, a topic not normally discussed in previous similar studies. A total of 120 patients with locally advanced or metastatic non-small-cell lung cancer (NSCLC) were treated with a moderate-dose palliative chemotherapy regimen consisting of mitomycin C 8 mg m-2 i.v. on day 1 (alternate courses), vinblastine 6 mg m-2 i.v. on day 1 and cisplatin 50 mg m-2 i.v. on day 1 (MVP), repeating every 21 days for a maximum of six courses. Thirty-eight of 118 assessable patients (32%) achieved an objective response. Patients with locally advanced disease (stage IIIB) had a significantly better response rate (52%) than those with metastatic disease (25%) (P < 0.01). In 76 out of 110 (69%) patients, with tumour-related symptoms including 24 out of 31 patients (78%) with locally advanced disease, symptoms completely disappeared or substantially improved. In only 15 patients (14%) did symptoms progress during treatment. Symptomatic improvement was achieved after one course of chemotherapy in 61% and after two courses in 96% of responding patients. The schedule was well tolerated. Only 19% developed WHO grade 3/4 nausea/vomiting, and only 3% developed significant alopecia. Other toxicities were minimal. MVP is a pragmatic inexpensive chemotherapy regimen that offers useful symptom palliation in patients with advanced NSCLC and merits a 1-2 course therapeutic trial in such patients. The schedule should also be assessed as primary (neoadjuvant) chemotherapy before radical radiotherapy for locally advanced NSCLC in a randomised trial.     

MVP与HVP方案治疗晚期NSCLC前瞻随机研究

 目的　比较MVP(MMC +VDS +DDP)与HVP(HCPT +VDS +DDP)方案治疗晚期非小细胞肺癌 (NSCLC)的近期、远期疗效和不良反应。方法　将 88例NSCLC随机分为MVP组和HVP组 ,分别给予MVP和HVP方案化疗 3～ 5周期 ,按WHO标准评定疗效和不良反应。结果　两组有效率 (CR +PR)分别为 36 %和 2 6 % ,二组间疗效差异无显著性意义 (P >0 .0 5 )。二组中位缓解期、中位生存期、1年生存率和 2年生存率相似。二组主要毒副反应有骨髓抑制和消化道反应 ,二组毒副反应相似。结论　MVP方案疗效稍高于HVP方案 ,所以化疗时宜选MVP方案     

Compliance with post-operative adjuvant chemotherapy in non-small cell lung cancer. An analysis of National Cancer Institute of Canada and intergroup trial JBR.10 and a review of the literature

Resected non-small cell lung cancer (NSCLC) has 5-years survival rates of 30-70%. The role of adjuvant chemotherapy remains unclear with poor compliance reported in most trials. The compliance with adjuvant chemotherapy (ACT) for stage IB and II NSCLC was analyzed using data from a North American multi-centre phase III study (accrual 1994-2001) that compared adjuvant chemotherapy to observation. Planned chemotherapy consisted of cisplatin (CIS) 50 mg/m2 days 1, 8 and vinorelbine (VIN) 25 mg/m2 days 1, 8, 15, 22 for four cycles; the VIN dose had been reduced from 30 mg/m2 after an initial cohort of patients experienced unacceptable toxicity. Four hundred and twenty-four patients were randomized after the amendment, 215 to the chemotherapy arm. Median age was 60 years, 64% were male and 84% had stage II disease. Thirty-seven patients completed one cycle, 14 completed two, 20 completed three and 108 patients completed all four cycles. Ten patients received no therapy. Multivariate analysis demonstrated statistically significant differences in compliance with extent of surgery, gender and age. Patients randomized in Canada were more likely to fail to complete chemotherapy due to refusal of therapy than their American counterparts. Patients who had pneumonectomies were more likely to discontinue therapy due to toxicity than those who had lesser resections. Extent of surgery may play a role in both the compliance and toxicity of ACT. Differences between nations in the perception of the risks and benefits of adjuvant chemotherapy regimens, both between physicians and patients, should be investigated further.     

NP和MVP方案治疗非小细胞肺癌的初步比较

目的]初步比较NP和MVP方案对晚期非小细胞肺癌(NSCLC)的疗效和不良反应。[方法]45例Ⅲ期或Ⅳ期NSCLC患者随机分为A组和B组 ,A组应用NP(去甲长春花碱 顺铂)方案化疗 ,B组应用MVP(丝裂霉素 长春花碱酰胺 顺铂)方案化疗 ,至少连用2周期后评价疗效和不良反应。[结果]两组均无完全缓解病例 ,A组有效率为45 5 %(10/22) ,B组35 0 %(7/20) ,差异无显著性(P>0 05)。其中对腺癌有效率A组为53 3 %(8/15) ,B组为35 7%(4/14)。A组静脉炎发生率为27 3 %(6/22) ,B组为0(P<0 05) ;其它不良反应两组均相似。[结论]NP方案为治疗晚期NSCLC较为有效和安全的化疗方案。