Pathological complete response to long-course neoadjuvant alectinib in lung adenocarcinoma with EML4-ALK rearrangement: report of two cases and systematic review of case reports.

Objective: Despite the promising efficacy and tolerability of alectinib in treating advanced anaplastic lymphoma kinase (ALK) positive non-small cell lung cancer (NSCLC), the role of alectinib in neoadjuvant setting remains understudied in ALK-rearranged resectable lung cancer. Methods: Our report concerns two cases of early-stage NSCLC with complete pathologic responses to off-label use of long-course neoadjuvant alectinib. PubMed, Web of Science, and Cochrane Library were searched comprehensively for ALK-positive resectable cases with neoadjuvant alectinib. The papers were chosen following PRISMA recommendations. Seven cases from the literature and two present cases were evaluated. Results: Two cases with stage IIB (cT3N0M0) EML4-ALK lung adenocarcinoma received long-course (more than 30 weeks) of neoadjuvant alectinib followed by R0 lobectomy with the complete pathological response. In our systematic review, 74 studies were included in the original search. Application of the screening criteria resulted in 18 articles deemed eligible for full-text reading. Following the application of the exclusion criteria, out of six papers, seven cases were selected for inclusion in the final analysis and were included in the systematic review. None of the studies were included in the quantitative analysis. Conclusion: We report two cases of lung adenocarcinoma with resectable ALK-positive that achieved pCR with long-course neoadjuvant alectinib. Our cases and a systematic review of the literature support the feasibility of neoadjuvant alectinib treatment for NSCLC. However, large clinical trials must be conducted in the future to determine the treatment course and efficacy of the neoadjuvant alectinib modality. Systematic review registration: https://www.crd.york.ac.uk/PROSPERO, identifier CRD42022376804.

Genetic profiling of circulating cell-free DNA from cerebrospinal fluid and paired plasma in ALK-positive lung cancer with brain metastases.

BACKGROUND: This study used next-generation sequencing (NGS) to investigate the genetic profiles in cerebrospinal fluid (CSF), plasma, and tumor tissue to explore alternative detection methods for anaplastic lymphoma kinase (ALK) rearrangement status and potential resistance mechanisms to ALK inhibitors. METHODS: From January 2016 to January 2021, 19 non-small cell lung cancer (NSCLC) patients with brain metastases (BMs) and ALK-positive primary tumors were enrolled at Beijing Chest Hospital. CSF, plasma, and primary tumor samples from patients with BMs of NSCLC were tested using NGS with a 168-gene panel. The intracranial response and prognosis were also investigated. RESULTS: The study included 19 patients, seven females and 12 males, aged between 29 and 68 (median age 44). CSF cytology was negative in all cases. NGS results showed ALK fusion genes detected in 26.3% (5/19) of CSF cfDNA samples, 78.9% (15/19) of plasma samples, and 89.5% (17/19) of tumor samples from ALK-positive patients. ALK-positive CSF samples had significantly higher allele fractions in CSF cfDNA compared with the other two sample types. In five patients with ALK-positive in CSF, after receiving ALK inhibitors ± local treatment, one case achieved an intracranial complete response, and two had an intracranial partial response. In CSF samples, the intracranial median progression-free survival was 8.0 and 18.0 months for ALK-positive (n = 5) and ALK-negative (n = 14), respectively (p = 0.077). CONCLUSION: CSF may serve as a liquid biopsy for ALK-positive lung cancer with BMs by detecting cfDNA within CSF to characterize driver and resistant genes.

Pathologic response and safety to neoadjuvant PD-1 inhibitors and chemotherapy in resectable squamous non-small-cell Lung cancer.

Background: Several randomized studies have shown that the combination of programmed cell death 1 (PD-1) inhibitor and chemotherapy is efficacious as a treatment for advanced non-small-cell lung cancer (NSCLC). However, in the neoadjuvant setting, there is scarce evidence of the effectiveness and safety of the combinations in squamous NSCLC. We conducted a retrospective study to evaluate neoadjuvant PD-1 inhibitor plus chemotherapy in resectable squamous NSCLC. Methods: Patients from Beijing Chest Hospital, Capital Medical University, between October 2019 and October 2021, treated with PD-1 inhibitors and chemotherapy for resectable squamous NSCLC were retrospectively studied. The primary objectives were to assess the pathological tumor response and safety of neoadjuvant PD-1 inhibitors and chemotherapy. Results: 63 patients with resectable squamous NSCLC stage IIA-IIIB were included. Two to four cycles of PD-1 inhibitors (37 cases with camrelizumab, 11 cases with toripalimab, 8 cases with tislelizumab, and 7 cases with sintilimab) and chemotherapy were administered prior to surgery. 42 patients (66.7%) achieved a major pathologic response (MPR), including 25 (39.7%) with a pathologic complete response (pCR). Twenty-one patients (33.3%) experienced grade 3 neoadjuvant treatment-related adverse events (TRAEs), and no patient had grade 4 or 5 TRAE. Conclusion: Neoadjuvant PD-1 inhibitors and chemotherapy are feasible therapies for resectable squamous NSCLC. It was associated with a 66.7% MPR rate, 39.7% pCR rate, and tolerable toxicity.

Detection of EGFR Mutations in Cerebrospinal Fluid of EGFR-Mutant Lung Adenocarcinoma With Brain Metastases.

BACKGROUND: We aimed to investigate the feasibility of detecting epidermal growth factor receptor (EGFR) mutations in cell-free DNA (cfDNA) from cerebrospinal fluid (CSF) and plasma of advanced lung adenocarcinoma (LADC) with brain metastases (BMs) by droplet digital polymerase chain reaction (ddPCR). METHODS: Thirty advanced LADC patients with BMs were enrolled, and their matched CSF and plasma samples were collected. Droplet digital PCR was used to test cfDNA in CSF and plasma for EGFR mutation status. The clinical response and prognosis were evaluated. RESULTS: Out of 30 patients, there were 21 females and 9 males, aged 34-75 years. In all of the cases, CSF cytology were negative. In ddPCR assays, 10 patients (33.3%) had EGFR mutation in CSF, including 3 cases of EGFR T790M mutation, and 16 patients (53.3%) had EGFR mutation in plasma, including 6 cases of EGFR T790M mutation. Five patients with activating EGFR mutations in CSF achieved an intracranial partial response (iPR) after combination treatment with the first-generation EGFR-tyrosine kinase inhibitors. Three patients with EGFR T790M mutations in CSF achieved iPR after second-line osimertinib treatment. The median overall survival and intracranial progression-free survival were 17.0 months and 11.0 months, respectively. CONCLUSION: It was feasible to test EGFR mutation in cerebrospinal fluid and plasma. In LADC patients with brain metastasis, cerebrospinal fluid can be used as a liquid biopsy specimen to guide treatment strategy by monitoring EGFR mutation status.

ALK-rearranged squamous cell carcinoma of the lung.

BACKGROUND: ALK rearrangement is a very rare subset of squamous cell carcinoma (SCC) and one of the clinical features in patients is lack of data. Here, we report eight patients diagnosed with SCC of the lung harboring ALK rearrangement. METHODS: We collected primary NSCLC samples at the Beijing Chest Hospital between January 2012 and December 2018 for Ventana (D5F3) immunohistochemical detection. Among the 148 patients was diagnosed ALK-rearranged non small cell lung cancer (NSCLC), only eight cases was SCC. We collected patients information from electronic patent records (EPRs). RESULTS: The eight cases of SCC were diagnosed by immunohistochemistry (IHC). Two were given crizotinib as second-line therapy. One patient had stable disease (SD) and progression-free survival (PFS) of six months. The other patient had progressive disease (PD) but PFS was only one month. The side effects were tolerable. This report identified 31 cases of ALK rearrangement in SCC patients from a literature search (including the eight patients in this study). These fusion genes are often seen in a younger age group (mean age: 55.6 years) and non-smokers (18/31, 58.1%). A total of 20 cases received an ALK inhibitor as first- or second-line treatment which included 11 with a partial response (PR), four with SD, and five with PD. The DCR and ORR was 75.0% (15/20) and 55.0% (11/20), respectively. The median duration time of therapy was 6.4 ± 4.4 months. CONCLUSIONS: Patients with ALK-rearranged SCC obtained clinical benefit from ALK-inhibitor therapy, especially those who were non-smokers and whose tumors had been identified by IHC+/FISH+.

Outcomes of bevacizumab combined with chemotherapy in lung adenocarcinoma-induced malignant pleural effusion.

BACKGROUND: VEGF is critical in the pathogenesis of malignant pleural effusion (MPE). To understand the clinical benefits of antiangiogenic agents, the efficacy of chemotherapy containing bevacizmab was investigated in patients with lung adenocarcinoma-induced MPE. METHODS: The data of lung adenocarcinoma patients with MPE treated with bevacizumab plus chemotherapy on day 1, every three weeks, for ≤ 6 cycles was retrospectively collected. Patients who achieved a response or stable disease were administered bevacizumab as maintenance therapy until progression. The primary outcomes of the study were MPE response rate (RR), MPE control rate, and pleural progression-free survival (PPFS), while the secondary outcomes were PFS, overall survival (OS), changes to the lung volume and thoracic cage, and safety profiles. RESULTS: A total of 21 cases were collected, and all were evaluable for response, including 15 chemotherapy-naïve patients and 6 who experienced relapse. The median cycle of treatments was 7 (1-42) and 5 (2-6) for bevacizumab and chemotherapy, respectively. The MPE RR reached 81.0%. The MPE control rate at 6, 12, 24, 48, and 96 weeks were 95.2%, 90.0%, 89.5%, 73.7%, and 43.8%, respectively. Median PPFS was significantly longer than PFS (22.2 vs. 7.8 months; P = 0.044), and median OS was 25.8 months. Nineteen (90.5%) patients experienced lung re-expansion after treatment. Only one (4.8%) patient suffered thoracic volume decrease during treatment and the follow-up period. No unexpected adverse events were observed. CONCLUSIONS: Bevacizumab combined with chemotherapy demonstrated efficacious, persistence, and safety in controlling lung cancer-induced MPE, indicating a potential superior therapeutic option.

[Adverse events of afatinib as first-line treatment for five cases of advanced lung adenocarcinoma and review of literature].

BACKGROUND AND OBJECTIVE: Afatinib is an irreversible ErbB-family blocker with a clinical activity in non-small cell lung cancer with epidermal growth factor receptor (EGFR) mutations. The aim of this study is to assess the safety of afatinib in patients with advanced lung adenocarcinoma. METHODS: Patients with lung adenocarcinoma (stage IIIb or IV) with EGFR mutations were first-line treated with an oral administration of afatinib (40 mg/d) until disease progression. Adverse events, effects, and survival condition were observed. RESULTS: The most common adverse events were diarrhea (n=5, 100%), skin rash (n=4, 80%), and mucositis/stomatitis (n=4, 80%). Moderate toxicities not exceeding grade 3 were observed. Relatively, the most serious adverse reaction was mucositis/stomatitis. Mild diarrhea occurred in all patients. Three patients experienced temporary drug withdrawal and dose reduction because of adverse reaction. Among the four patients who were evaluated, partial response was observed in two patients (50%), one with stable disease (25%) and one with progressive disease (25%). Median progression-free survival was 9.7 months, whereas median overall survival was 18.4 months. CONCLUSIONS: Afatinib was approved as first-line treatment for patients with advanced lung adenocarcinoma. The most common adverse events were diarrhea and skin rash. However, mucositis/stomatitis related to afatinib should also be considered. Considering the small number of cases, the conclusion requires more trials for confirmation.

[Long-term survival of a patient with advanced non-small cell lung cancer on bevacizumab therapy: case report and review of the literature].

We report an advanced stage Chinese female lung adenocarcinoma patient who was negative for epidermal growth factor receptor (EGFR), V-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog (KRAS) gene mutations, also negative for chinodem microtubule-associated protein-like 4/anaplastic lymphoma kinase (EML4-ALK) gene rearrangement and treated with bevacizumab (15 mg/kg) in combination with 6 cycles of conventional doses of paclitaxel and carboplatin chemotherapy. She was then treated with maintenance bevacizumab for a total of 42 cycles, the total dose of bevacizumab is 44,730 mg. The progression-free survival was 39 months. Our findings suggest that maintenance bevacizumab for the treatment of non-small cell lung cancer (NSCLC) is safe and its benefit for long-term survival overwhelms its side effects.

[Vandetanib treatment in refractory advanced lung adenocarcinoma patients: five cases and review of literature].

BACKGROUND AND OBJECTIVE: Vandetanib is a once-daily oral multi-target inhibitor of vascular endothelial growth factor receptor, epidermal growth factor receptor, and rearranged during transfection (RET) tyrosine kinases. The current study aimed to evaluate the effect and safety of vandetanib administered in refractory advanced lung adenocarcinoma patients. METHODS: Five patients who accepted chemotherapy and Tarceva therapy as first- and second-line treatments received vandetanib (300 mg, oral, once daily). RESULTS: The effects are stable disease on two patients (40%) and progressive disease on three patients (60%). With a median follow-up of 36 months, one patient remained on follow-up. The median progression free survival (PFS) is 2 months, and the mean overall survival is 22.6 months. The adverse events include rash (n=2), skin change (n=2), paronychia (n=2), asymptomatic QTc prolongation (n=2), ST-T change (n=1), diarrhea (n=1), and increased transaminase (n=1). CONCLUSIONS: There were lower incidences of severe side effects with vandetanib therapy in refractory advanced lung adenocarcinoma patients. The results of effect and safety of vandetanib are similar with the related reviewed articles.

[Comparison of Oral Topotecan/Intravenous Cisplatin (TC) with Intravenous Etoposide/Cisplatin (EP) as First Line Chemotherapy in Untreated Small Cell Lung Cancer Patient.].

BACKGROUND: Topotecon is a specific inhibitor of topoisomerase I. It is an effective drug of small cell lung cancer. An oral formulation of topotecan is available and has just rectified to treat extensivedisease small cell lung cancer by FDA this year. The aim of this trial is to compare oral topotecan/intravenous cisplatin (TC) with intravenous etoposide/cisplatin (EP) in patients untreated small cell lung cancer. METHODS: Sixty-six patients were enrolled. Thirty patients were assigned to oral topotecan 1.4 mg*m(-2)*d(-1), from d1 to d5, with cisplatin 75 mg/m(2) on d1. Thirty-six patients were assigned to etoposide 100 mg*m(-2)*d(-1), from d1 to d3, with cisplatin 75 mg/m(2) on d1 every 21 days. RESULTS: Response rate was similar between groups TC, 53.3% vs EP, 60.0%. Overall survival was little different TC, 14.58 month vs EP, 12.19 months. The regimens were similarly tolerable. Grade 3/4 neutropenia and thrombocytopenia occurred more frequently with EP (42.8% vs 10.0% and 11.4% vs 3.3%, respectively), whereas grade 3/4 anaemia occurred more frequently with TC (10% vs 2.8%). CONCLUSIONS: Oral topotecan/cisplatin provide similar efficacy and tolerability to the standard etoposide/cisplatin in patient untreated small cell lung cancer. It may provide more convenience method to intravenous treatment.

[Acceptable safety of bevacizumab therapy in combination with chemotherapy in patients with advanced lung cancer.].

BACKGROUND: Bevacizumab is a recombinant humanized monoclonal IgG1 antibody that selectively binds to and neutralizes the biologic activity of human vascular endothelial growth factor (VEGF). Bevacizumab was approved by the U.S. Food and Drug Administration (FDA) in October 2006 for use in combination with carboplatin and paclitaxel for the initial treatment of patients with unresectable, locally advanced, recurrent, or metastatic, nonsquamous, non-small cell lung cancer (NSCLC). The aim of this study is to observe the safety of bevacizumab therapy in combination with chemotherapy in Chinese patients with NSCLC. METHODS: Patients with advanced non-squamous NSCLC were treated with Bevacizumab 15 mg/kg, d1, repeated every 21 days until PD; Plus paclitaxel 175 mg/m(2), on dl and carboplatin AUC=6 on dl. The cycle was repeated every 21 days. RESULTS: One grade 3 epistaxis was observed in one patient. One grade 4 thrombosis was observed in one patient. 3/4-grade epistaxis and thrombosis was the most significant adverse events. Other adverse effects, such as hemoptysis, hypertension and proteinuria, were not severe and could be well tolerated. CONCLUSIONS: Most chemotherapy-naive patients with advanced non-squamous NSCLC treated with bevacizumab in combination with paclitaxel and carboplatin have little adverse effects that can be well tolerated.

[Clinical Observation of Erlotinib in the Treatment of Advanced and Previously Treated Non-small Cell Lung Cancer.].

BACKGROUND: Erlotinib is a small molecular inhibitor of tyrosine kinase. One study has confirmed that it can prolong the median progression-free survival time (PFS), and can improve the one-year survival rate of patients with advanced non-small cell lung cancer. The aim of this trial is to evaluate the response and adverse reaction of agent erlotinib in advanced and previously treated non-small-cell lung cancer. METHODS: The study was one part of the EAP (Expanded Access Programme) study. Forty-five patients with advanced non-small cell lung cancer, which had been treated with 1-2 regimens containing platinum previously, were treated with erlotinib from Dec 2005. Erlotinib was prescribed at a dose of 150 mg daily. RESULTS: Forty-three patients were evaluated response and all patients were evaluated toxicity. Among these patients, CR 0 case, PR 19 cases (44.2%), RR (CR+PR) 44.2% and SD 13 cases as their best response, disease control rate (DCR=CR+PR+SD) 74.4%, PD 11cases (25.6%). The median progression-free survival time was 4.8 months; the median survival time was 15.0 months; the one-year survival rate was 68.8% (31/45). The median PFS of patients with adenocarcinoma and with non-adenocarcinoma was 7.6 months vs 2.6 months (P=0.018). The drug-related adverse reactions were skin rash (41 cases, 91.1%), billirubine increased (15 cases, 33.3%), ALT increased (9 cases, 20%) and diarrhea (4 cases, 8.9%). For patients with and without skin rash, the median PFS was 7.5 months vs 1.1 months (P=0.001), and the median survival time was 15.6 months vs 5.2 months (P=0.002). CONCLUSIONS: Erlotinib is effective in advanced and previously treated non-small cell lung cancer, and it is much more effective in adenocarcinoma and patients with skin rash. It is well tolerated, only with some minimal adverse reactions.

[A Retrospective Study of Erlotinib in the Treatment of 70 Patients with Non-small Cell Lung Cancer.].

BACKGROUND: Erlotinib is a small molecular inhibitor of tyrosine kinase. Multiple foreign and demestic studies have confirmed that it can prolong the median progression-free survival time (PFS) and the overall survival (OS), which could be more significant in the selected population. In this study we retrospectively oberserved the response, the survival and adverse reaction of erlotinib in non-selected non-small cell lung cancer. METHODS: The retrospective study included seventy non-small-cell lung cancer patients, who were treated with erlotinib from July 2005 to July 2009. Erlotinib was prescribed at a dose of 150 mg daily. RESULTS: Sixty-eight patients were evaluated response. Among these patients, CR 0 case, PR 26 cases, RR (CR+PR) 38.2% and SD 24 cases as their best response, disease control rate (DCR=CR+PR+SD) 73.5%, PD 18 cases (26.5%). Sixty-three patients were evaluated PFS. The median PFS was 3.0 months. The median PFS of adenocarcinoma and non-adenocarcinoma was 3.0 months vs 2.6 months. The drug-related adverse reactions were skin rash, diarrhea and interstitial lung disease (ILD)(4.3%). CONCLUSIONS: Erlotinib is active in non-small cell lung cancer, and it is much more effective in adenocarcinoma and non-smoking patients. There is no difference in response or suvival concerning the sexuality. It is well tolerated in most patients.

[The relationship between EGFR mutations and response and prognosis of tyrosine kinase inhibitors in advanced Non-small-cell Lung Cancer.].

BACKGROUND: It has been proven that epigermal growth factor receptor (EGFR) signal pathway plaied an important role in the oncogenesis and development of non-small cell lung cancer (NSCLC). EGFR tyrosine kinase inhibitors (EGFR-TKIs) are currently investigated in the treatment of NSCLC. It was suggested in previous studies that the EGFR gene mutations were correlated with the response to EGFR-TKIs therapy and prognosis of NSCLC. We studied the role of EGFR gene mutations in response to two kinds of TKIs therapy and prognosis of NSCLC in this study. METHODS: The tissue samples of 59 advanced NSCLC patients (34 patients receiving Gefitinib monotherapy and 25 patients receiving Erlotinib monotherapy) were collected, and patient charts were reviewed. The mutations in exons 19 and 21 of EGFR gene were detected by PCR-PAGE and PCR-RFLP respectively. The sequences of interested fragments were verified by direct sequencing. Relationship between EGFR mutation and response to TKIs therapy was analyzed with Chi-Square test. RESULTS: EGFR gene mutations were identified in 22 of 59 samples (37.3%). EGFR gene mutation rate was significantly higher in female, non-smoker and patients with adenocarcinoma than in others (50% vs 18.9%, P <0.05). The patients with EGFR gene mutation had a better response to TKIs therapy than those without (86.4% vs 54.1%,P <0.05). The patients with EGFR gene mutation had slower disease progression and longer overall survival than those without, but statistically non-significant (P >0.05). CONCLUSIONS: EGFR gene mutation occurs more frequently in female, non-smoker and patients with adenocarcinoma. In patients with advanced NSCLC, EGFR mutation is associated with good response to EGFR-TKIs therapy.

[Target therapy of gefitinib in advanced adenocarcinoma of the lung].

BACKGROUND: Gefitinib is an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor which is used to treat advanced non-small cell lung cancer, especially adenocarcinoma. The aim of this study is to evaluate the efficacy, side effects and prognostic factors of gefitinib in adenocarcinoma of the lung. METHODS: A total of 26 patients with advanced adenocarcinoma of the lung were enrolled in the study. Gefitinib was orally administered 250mg once daily until disease progression or the occurrence of intolerable toxicity. They were evaluated regularly and their survival was analyzed. RESULTS: In 26 patients, there was 1 with complete regression (3.8%), 11 with partial response (42.3%), 9 with stable disease (34.6%) and 5 with progression of disease (19.2%). The objective response rate was 46.2% and the disease control rate was 80.8%. The median progression-free survival time was 8.2 months and the median overall survival time was 10.4 months. The 1-year survival rate was 31.6%. Age ( < 70 years old), skin rash and CEA decrease were significantly related to longer survival, however, times of prior chemotherapy and gefitinib treatment stage did not influence the survival. Mean PS (ECOG) was 3.0 before treatment, and 1.8 after treatment. Mean symptom relief time was 5.2 days. CONCLUSIONS: Gefitinib is an effective target drug with slight side effect. It can significantly improve quality of life of patients with adenocarcinoma. It can be used as first-line therapy to patients who are not suitable for chemotherapy.

[A randomized clinical trial of Uroacitides combined with NP and NP regimen alone for advanced non-small cell lung cancer].

BACKGROUND: Uroacitides is a group of cell differentiation inducers, which is purified from fresh human urine. Preclinical studies of Uroacitides have showed that cancer cells could be induced to differentiate, and the growth of cancer cells could be inhibited by Uroacitides. The aim of this study is to compare the efficacy and toxicity between Uroacitides combined with NP regimen and NP alone in treatment of advanced non-small cell lung cancer (NSCLC). METHODS: Forty-two cases of advanced NSCLC were randomized into Uroacitides+NP and NP groups. NP group: NVB 25mg/m² on days 1 and 8, DDP 75mg/m² on day 1. Uroacitides combined with NP group: Uroacitides of 300mL was given through subclavian catheter daily for 7 days prior to the NP chemotherapy, then concurrently with NP regimen for 2 cycles, except the days of administration of chemotherapy. RESULTS: In the Uroacitides+NP group, the overall response rate was 44.4%, and 20.0% in the NP group (P > 0.05). The median survival time was 9 months in the Uroacitides+NP group and 6 months in the NP group (P=0.0287). The main toxicities were myelosuppression, gastrointestinal reaction and alopecia, and there was no significant difference in incidences of toxicities between the two groups (P > 0.05). CONCLUSIONS: Uroacitides combined with NP regimen shows a good curative effect and low toxicity, and may significantly prolong the median survival time for advanced NSCLC.

[Paclitaxel combined with platinum-based chemotherapy as second-line treatment in patients with advanced non-small cell lung cancer: A forty case-report].

BACKGROUND: To evaluate the activity and toxicity of paclitaxel as second-line treatment for advanced non-small cell lung cancer (NSCLC). METHODS: Forty patients with recurrent advanced NSCLC were enrolled. Thirty-six patients were managed with regular regimen. Paclitaxel 135 mg/m², 3 h, on day 1; DDP 75 mg/m² or carboplatin 300-350 mg/m² on day 2. Four patients were managed with weekly regimen. Paclitaxel 60 mg/m²,3 h, on days 1,8,15; DDP 75 mg/m² on day 2. It was repeated every three or four weeks, up to two to four cycles. RESULTS: Thirty-six cases were evaluated for response and 27 for survival. The objective response rate was 13.9% (5/36). At least one tumor-related symptom relief was observed in 21 patients (58.3%). The median survival duration was 26.4 weeks and 1-year survival rate was 8% (4/36). The main toxicities included myelosuppression, fatigue and myalgia-arthralgia neuropathy. CONCLUSIONS: Paclitaxel has advantage to be well-tolerated and improve tumor-related symptom. Further studies with standardization of dose and regimen will be needed to clarify its role in the second-line treatment.

[Clinical research on combined chemotherapy of vinorelbine and cisplatin in the treatment of non-small cell lung cancer].

BACKGROUND: To evaluate the efficacy, side-effects, median survival duration and survival rate of vinorelbine (NVB) combined with cisplatin (DDP) in the treatment of non-small cell lung cancer (NSCLC). METHODS: A total of 220 patients with inoperable NSCLC received NVB and DDP combined chemotherapy: NVB 25-30 mg/(m²*d) on days 1 and 5 (or 8), DDP 60-80 mg/(m²*d) on day 2. The schedule was repeated every 28 days. The efficacy and side-effects were analysed and followed-up after at least two cycles of chemotherapy. RESULTS: The overall response rate (CR+PR) was 30.9% (68/220). The response rate was 31.3% (51/163) in initial treatment group, and 29.8% (17/57) in retreatment group. The median survival duration was 8.3 months. The 1-, 2- and 3-year survival rates were 39.23%, 19.31% and 6.32%, respectively. The main side-effects were myelosuppression and digestive tract reactions. CONCLUSIONS: Vinorelbine plus cisplatin is an effective and well-tolerated regimen for non small cell lung cancer and myelosuppression is its dose-limiting toxicity.

[Serratia marcescens vaccine in the treatment of malignant pleural effusion].

OBJECTIVE: To evaluate the efficacy and toxicity of Serratia marcescens (S311) vaccine in the treatment of malignant pleural effusion. METHODS: Thirty-four patients with malignant pleural effusion were given S311 as intrapleural injection with a dose of 10(9) U (0.32 mg) on D 1, 8 and 15, and observed for four weeks. RESULTS: The overall response rate (CR + PR) was 97.1% (CR in 12 patients and PR in 21 patients). The systemic toxicity was mild, including fever (82.4%), pleuritic pain (50.7%), nansea (26.5%), dyspnea (17.5%) and chills (5.9%). CONCLUSION: Serratia marcescens vaccine is effective for malignant pleural effusion, with tolerable toxic effects. Further study is warranted.