scholarly journals A Retrospective Analysis of the Effect of Anlotinib in Patients With Lung Cancer With or Without Previous Antiangiogenic Therapy

2021 ◽  
Vol 11 ◽  
Author(s):  
Jiaojiao Suo ◽  
Yu Sun ◽  
Yan Fu ◽  
Weigang Xiu ◽  
Xuanwei Zhang ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Antiangiogenic Therapy ◽  
Objective Response ◽  
Progression Free Survival ◽  
Free Survival ◽  
Prior Use ◽  
Metastatic Lung ◽  
Group A ◽  
Antiangiogenic Drugs ◽  
Group B

ObjectiveThe purpose of this study was to initially investigate the effect of previous antiangiogenic therapy (bevacizumab and endostatin) on the efficacy of anlotinib in patients with advanced or metastatic lung cancer (LC).MethodsWe retrospectively collected the clinical data of patients with LC treated with anlotinib and divided them into group A (treated with anlotinib after the failure of previous antiangiogenic drugs and group B (no prior use of antiangiogenic drugs). We used propensity score matching (PSM) for confounding factors between the groups. Progression-free survival (PFS) and overall survival (OS) were also recorded.ResultsA total of 160 patients were included in the analysis. The median OS in groups A and group B was 11.8 months and 16.1 months (P=0.120), whereas the median PFS was 3.1 months and 4.7 months (P=0.009), respectively. Moreover, the objective response rate (ORR) of the two groups was 9.6% and 10.4% (P=0.874), and the disease control rate (DCR) was 71.1% and 80.5% (P=0.165).After PSM (n=46), baseline characteristics were comparable between groups A and B. Furthermore, the median OS of the two groups was 14.6 months and 16.2 months (P=0.320), whereas the median PFS was 3.5 months and 4.5 months (P=0.040), respectively. Moreover, the ORR of the two groups were 13.0% and 10.9% (P=0.748), and the DCR were 78.3% and 82.6% (P=0.599), respectively.ConclusionsPrevious antiangiogenic treatments may affect the PFS of patients who receive anlotinib later, but it might not affect the patient’s ORR and OS.

scholarly journals Anlotinib Is Active for the Patients Failed From the Prior Antiangiogenic Therapy: Anti-angiogenic Therapy Might Be Cross-line Used

2021 ◽  
Author(s):  
Jiaojiao Suo ◽  
Yu Sun ◽  
Yan Fu ◽  
Weigang Xiu ◽  
Xuanwei Zhang ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Propensity Score ◽  
Antiangiogenic Therapy ◽  
Confounding Factors ◽  
Angiogenic Therapy ◽  
Prior Use ◽  
Group A ◽  
Antiangiogenic Drugs ◽  
Baseline Characteristics ◽  
Group B

Abstract Objective The purpose of this study was to initially investigate whether previous antiangiogenic therapy (bevacizumab and endostar) affect the efficacy of anlotinib in patients with lung cancer (LC). Methods We retrospectively collected the clinical data of LC patients treated with anlotinib. They were divided into two groups, namely group A (anlotinib after failure of previous antiangiogenic drugs and group B (no prior use of antiangiogenic drugs). Use propensity score matching (PSM) to control the confounding factors between the groups.Results A total of 160 patients were included in the analysis. The median OS in group A and group B was 11.8 months vs. 16.1 months (P=0.120), and the median PFS was 3.1 months, 4.7 months, respectively (P=0.009). The ORR of the two groups was 9.6% vs. 10.4% (P=0.874), and the DCR was 71.1 % vs. 80.5% (P=0.165).After PSM (n=46), baseline characteristics were equitably comparable between the two groups. It was found that the median OS of the two groups was 14.6 months vs. 16.2 months (P=0.320), and the median PFS was 3.5 months vs. 4.5 months (P=0.040). The ORR of the two groups were 13.0%, 10.9% (P=0.748), and the DCR were 78.3%, 82.6% (P=0.599), respectively. These results provided further evidence that although PFS of group A was relatively shorter than that of group B, it may not affect patients’ OS.Conclusions Previous antiangiogenesis treatments may affect the PFS of patients who receive anlotinib later, but it might not affect the patient’s ORR and OS.

A prospective, nonrandomized phase II/III trial of definitive chemoradiation, with or without cetuximab, in advanced esophageal squamous cell carcinoma.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e14645-e14645
Author(s):  
Yongshun Chen ◽  
Jianhua Wang ◽  
Xiaoyuan Wu ◽  
Chunyu He ◽  
Wen Wang ◽  
...  
Keyword(s):  
Squamous Cell Carcinoma ◽  
Esophageal Squamous Cell Carcinoma ◽  
Cell Carcinoma ◽  
Squamous Cell ◽  
Objective Response ◽  
Progression Free Survival ◽  
Chinese Patients ◽  
Free Survival ◽  
Group A ◽  
Group B

e14645 Background: Chemoradiotherapy is the standard treatment option for patients with esophageal cancer unsuitable for surgery, but the majority of patients will die of their disease, most commonly with local tumor progression/recurrence. We initiated this study to determine the efficacy and safety of the addition of cetuximab with paclitaxel, cisplatin, and radiation for patients with advanced esophageal squamous cell carcinoma (ESCC). Methods: A total of 127 patients with clinical stage II–IVa disease were selected to receive combined-modality therapy consisting of cetuximab (400 mg/m2/wk week 1, then 250 mg/m2/wk week 2-8), paclitaxel (45 mg/m2/wk) and cisplatin (20 mg/m2/wk) in weeks 2-8 with 59.4 Gy of radiation (Group A, n = 29) versus the same chemoradiotherapy schedule but without cetuximab (Group B, n = 98). Results: At the time of this analysis, 27 and 88 patients were available for evaluation of response and survival in Group A and B respectively. In Group A, 20 patients (74.1%) achieved complete response (CR) and 7 (25.9%) achieved partial response (PR), resulting in an objective response rate (ORR) of 100%. The 1- and 2-year progression-free survival (PFS) was 91.2% and 85.1%, the median PFS was not reached. No association between tumor EGFR expression and response or survival was found. In Group B, 33 patients (37.5%) achieved CR, 51 (58.0%) achieved PR and 4 (4.5%) had stable disease, thus the ORR was 95.5%. The 1- and 2-year PFS was 89.0% and 50.5%, with the median PFS of 24.3 months. The difference in PFS between the two groups was statistically significant (p = 0.011). Treatment-related toxicities were generally grade 1 or 2. The most common toxicities were rash (89.3%), followed by neutropenia (71.4%) and esophagitis (60.7%) in chemoradiation-plus-cetuximab group. Adverse events were most often neutropenia (81.8%) and esophagitis (76.1%) in chemoradiation group. Locoregional failure rate was 3.7% and 15.9% in Group A and B, respectively. Conclusions: Cetuximab can be safely administered with chemoradiation and may prolong progression-free survival for Chinese patients with ESCC.

Thalidomide Based Regimens (TBR) for Relapsed/Refractory Multiple Myeloma Patients: Long Term Follow Up, Unmaintained Remissions and Disease Control after Subsequent Treatments.

Blood ◽  
2007 ◽  
Vol 110 (11) ◽  
pp. 4812-4812
Author(s):  
Maria Roussou ◽  
Efstathios Kastritis ◽  
Athanasios Anagnostopoulos ◽  
Evangelos Eleftherakis-Papaiakovou ◽  
Charis Matsouka ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Progression Free Survival ◽  
Free Survival ◽  
Refractory Multiple Myeloma ◽  
Long Term Follow Up ◽  
Group A ◽  
Pulse Dexamethasone ◽  
Group B

Abstract Introduction: The effectiveness of thalidomide based regimens (TBR) in patients with relapsed/refractory multiple myeloma is well established. However, there are still limited data regarding the long term follow up after such regimens and the outcome of patients when they progress and they receive further treatment. In order to answer these questions we evaluated a series of 114 patients with relapsed/refractory multiple myeloma who were treated with TBR. None of these patients had previously received thalidomide, bortezomib or lenalidomide. Patients and Methods: All patients were treated with thalidomide and dexamethasone with or without other oral agents. More specifically 41 patients had received continuous thalidomide and pulse dexamethasone, 25 patients clarithromycin, continuous thalidomide and pulse dexamethasone, 43 patients intermittent thalidomide, pulse dexamethasone and cyclophosphamide and 5 patients continuous thalidomide, pulse dexamethasone and cyclophosphamide. Type of treatment at the time of progression after TBR, response to this treatment and progression free survival were recorded for each patient. Moreover, patients who received novel agents after progression to TBR, were divided into 2 subgroups, according to their resistance to thalidomide. In group A, patients had refractory or progressive myeloma while on TBR or within 2 months after discontinuation of TBR. In group B, myeloma progressed more than 2 months after discontinuation of TBR. Results: Among the 114 patients, 41 had not responded to TBR and 73 (64%) had achieved at least a partial response. The median PFS for all patients was 8 months. As of June 2007, 10 patients remain without progression from 28 to 81 months (median 54 months). Eight patients remain off treatment and without progression for a median of 56 months (range 28–81). Patients who did not respond to or progressed after TBR were analyzed for further treatment and outcome. Thirty eight patients (37%) died before receiving further treatment, 23 patients (23%) received conventional chemotherapy and 41 patients (40%) received continuous thalidomide and dexamethasone +/− clarithromycin or cyclophosphamide (17 patients), bortezomib and dexamethasone (7 patients), melphalan-bortezomib-dexamethasone and intermittent thalidomide (12 patients) or lenalidomide with dexamethasone (5 patients). Among these 41 patients, 24 were classified in group A (thalidomide resistant) and 17 in group B. Overall 17 (41%) achieved at least partial response after retreatment with novel agent-based regimens. A response was observed in 46% of patients in group A and in 35% of patients in group B. The median progression free survival of the 41 patients who received retreatment with novel agents was 9.2 months and the median survival was 17 months. Among the 23 patients who received conventional chemotherapy only five (21%) patients responded and the progression free survival and the median survival were 5.3 and 10.2 months, respectively. Conclusions: After an oral TBR regimen 6 (5%) patients remain without treatment and free of progression for more than 4 years. A significant number of patients who progressed after TBR and who received further treatment which included a novel agent achieved a response, including several patients who were resistant to TBR.

Retrospective analysis of first-line chemotherapy in 132 patients with advanced small-bowel adenocarcinoma.

2011 ◽  
Vol 29 (4_suppl) ◽  
pp. 260-260
Author(s):  
T. Tsushima ◽  
N. Boku ◽  
Y. Honma ◽  
H. Takahashi ◽  
S. Ueda ◽  
...  
Keyword(s):  
Small Bowel ◽  
Univariate Analysis ◽  
Objective Response ◽  
Progression Free Survival ◽  
Ampullary Carcinoma ◽  
Small Bowel Adenocarcinoma ◽  
Kaplan Meier ◽  
Group A ◽  
Group B ◽  
Ecog Ps

260 Background: No standard care has been established for advanced small-bowel adenocarcinoma (SBA). The aim of this study is to explore a most promising chemotherapy regimen for advanced SBA. Methods: All data were collected from medical records of patients with advanced or recurrent SBA who received chemotherapy between April 1999 and March 2009 at 41 hospitals in Japan. Selection criteria were as follows: 1) histologically proven SBA, excluding ampullary carcinoma, 2) no previous chemotherapy or radiotherapy, 3) ECOG PS 0-2, 4) adequate bone marrow, hepatic and renal functions, 5) no concomitant malignancy. Patients were divided into the five groups by regimens: group A, fluoropyrimidine alone; group B, fluoropyrimidine + cisplatin; group C, fluoropyrimidine + oxaliplatin; group D, fluoropyrimidine + irinotecan; group E, others. Progression-free survival (PFS) and overall survival (OS) were calculated by Kaplan-Meier method. Results: Demographics of selected 132 patients were: median age (range), 59 (23-78) years; male/female, 87/45; location of primary tumor, duodenum/jejunum/ileum/unknown, 80/32/17/3; advanced/recurrent disease, 91/41. The numbers of the patients in group A, B, C, D and E were 60, 17, 22, 11 and 22, and objective response rates (ORR) in the patients with target lesions were 20% (9/46), 38% (5/13), 42% (8/19), 25% (2/8), 21% (4/19), respectively. Median PFS and OS were 6.0 and 14.0 months for the whole population, and those in each group are shown in the Table.In comparison with fluoropyrimidine alone (A), oxaliplatin-combined regimens (C) associated with better PFS (HR=0.53 [0.31-0.93], p=0.03) and OS (HR=0.64 [0.33-1.25], p=0.19), while cisplatin-combined regimens (B) did not (HR=1.54 [0.88-2.68], p=0.13 for PFS and HR=1.67 [0.94-2.97], p=0.08 for OS) by univariate analysis. Conclusions: It is suggested that oxaliplatin-combined regimens might be the most promising regimen for advanced SBA. [Table: see text] No significant financial relationships to disclose.

Carboplatin-Paclitaxel Versus Cisplatin-Ifosfamide in the Treatment of Uterine Carcinosarcoma: A Retrospective Cohort Study

2014 ◽  
Vol 24 (7) ◽  
pp. 1256-1261 ◽  
Author(s):  
Domenica Lorusso ◽  
Fabio Martinelli ◽  
Maria Mancini ◽  
Italo Sarno ◽  
Antonino Ditto ◽  
...  
Keyword(s):  
Overall Survival ◽  
Area Under The Curve ◽  
Progression Free Survival ◽  
Oncologic Outcomes ◽  
Uterine Carcinosarcoma ◽  
Suitable Alternative ◽  
Free Survival ◽  
Gynecology And Obstetrics ◽  
Group A ◽  
Group B

ObjectiveUterine carcinosarcoma (CS) is a rare neoplasm whose adjuvant treatment has not been yet defined. We report on the activity and toxicity of cisplatin-ifosfamide and carboplatin-paclitaxel as adjuvant treatments for patients with uterine CS.MethodsData of International Federation of Gynecology and Obstetrics (FIGO) stage I to IV uterine CS patients treated between 2006 and 2012 with adjuvant chemotherapy (cisplatin 20 mg/mq and ifosfamide 1500 mg/mq day 1 to 4 every 3 weeks plus prophylactic Granulocyte colony-stimulating factor (G-CSF) support [group A] or carboplatin area under the curve -5 (AUC-5) and paclitaxel 175 mg/mq d1q21 [group B]) were retrospectively reviewed. Progression-free survival, overall survival, and chemotherapy-related toxicities were compared between the 2 groups. A subanalysis of oncologic outcomes according to the sarcomatous component (homologous vs heterologous) was performed.ResultsForty-six women were evaluated—21 in group A and 25 in group B. At a median follow-up of 30 months, the median progression-free survival was 11.6 months (95% confidence interval [CI], 6.3–16.9) and 16.6 months (95% CI, 14.7–18.5) for group A and B, respectively (P= 0.20). The median overall survival was 17.1 months (95% CI, 12.6–21.5) and 35.1 months (95% CI, 26.3–43.7) for group A and B, respectively (P= 0.14). No differences were identified among heterologous or homologous components according to chemotherapy treatment. Toxicity profiles widely differ between treatment arms.ConclusionsBecause of the super imposable activity and the better toxicity profile, carboplatin-paclitaxel may be a suitable alternative to cisplatin-ifosfamide in the treatment of uterine CS.

scholarly journals Abiraterone versus bicalutamide in combination with gonadotropin releasing hormone antagonist therapy for high risk metastatic hormone sensitive prostate cancer.

2021 ◽  
Author(s):  
Takashi Ueda ◽  
Takumi Shiraishi ◽  
Saya Ueda ◽  
Motoharu Ohashi ◽  
Toru Matsugasumi ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
High Risk ◽  
Progression Free Survival ◽  
Gonadotropin Releasing Hormone ◽  
Free Survival ◽  
Releasing Hormone ◽  
Group A ◽  
Psa Progression ◽  
Hormone Sensitive ◽  
Group B

Abstract ObjectivesTo compare the efficacy of abiraterone with that of bicalutamide in combination with gonadotropin-releasing hormone antagonist treatment for high risk metastatic hormone-sensitive prostate cancer patients.MethodsOne hundred and forty-nine patients with high risk metastatic hormone-sensitive prostate cancer at our hospital and affiliated hospitals between December 2013 and July 2020 were retrospectively identified. Fifty patients were administered abiraterone (1000mg/day) plus prednisolone (5mg/day) with gonadotropin-releasing hormone antagonist (degarelix) (group A) and 99 patients were administered bicalutamide (80mg/day) with gonadotropin-releasing hormone antagonist (group B). ResultsPSA- progression-free survival of group A was significantly longer than that of group B. Abiraterone therapy and Gleason score were significant independent factors for PSA-progression-free survival. By propensity score matching, total 56 matched patients were obtained. PSA-PFS (p<0.001) and OS (p=0.0071) of high risk mHNPC patients were significantly longer in abiraterone group of matched patients. Abiraterone therapy and Gleason score were still shown to be significant independent factors for PSA-PFS in matched patients.ConclusionsPSA-progression-free survival and overall survival in patients who were treated with abiraterone in combination with gonadotropin releasing hormone antagonist were significantly better than those of bicalutamide.

scholarly journals A Long Survival of III-IVb Stage Nasopharyngeal Carcinoma Treated with IMRT with or without Nimotuzumab: a Propensity Score-matched Analysis

2019 ◽  
Author(s):  
Wang Zhi-Qiang ◽  
Mei Qi ◽  
Li Ji-Bin ◽  
You Rui ◽  
Liu You-Ping ◽  
...  
Keyword(s):  
Nasopharyngeal Carcinoma ◽  
Propensity Score ◽  
Intensity Modulated Radiotherapy ◽  
Progression Free Survival ◽  
Chinese Patients ◽  
Term Survival ◽  
Free Survival ◽  
Distant Failure ◽  
Group A ◽  
Group B

Abstract Backgrounds: To assess the efficacy of Nimotuzumab in combination with first-line treatment of chemoradiotherapy of Chinese patients with primary III-IVb stage nasopharyngeal carcinoma. Methods: Patients with primary locoregionally advanced nasopharyngeal carcinoma who were treated with intensity-modulated radiotherapy (IMRT) and concurrent Cisplatin-based chemotherapy between January, 2008 and December, 2013 at a single institution were retrospectively reviewed. Group A received at least 6 doses of Nimotuzumab; Group B did not received Nimotuzumab. A propensity score matching method was used to match patients from each group in a 1:3 ratio. Results: In total, 730 eligible patients were propensity-matched, with 184 patients in Group A and 546 in Group B. There were no significant differences in patient and tumor characteristics between Group A and Group B. At a median follow-up of 74.78 months (range 3.53–117.83 months), locoregional recurrence, distant failure and death were observed in 10.68%, 11.10% and 16.03% of all patients, respectively. Estimated 5-year locoregional relapse–free survival, distant metastasis–free survival, progression-free survival and overall survival in the Group A versus Group B were: 85.34% versus 89.79% (P=0.156), 93.09% versus 85.61% (P = 0.012), 79.96% versus 77.99% (P = 0.117) and 88.91% versus 78.30% (P=0.006), respectively. Conclusions: This nimotuzumab-containing regimen resulted in a better long-term survival in III-IVb stage NPC patients, and warrants further prospective evaluation.

scholarly journals Fostering efficacy of anti-PD-1-treatment: Nivolumab plus radiotherapy in advanced non-small cell lung cancer - study protocol of the FORCE trial

BMC Cancer ◽  
2019 ◽  
Vol 19 (1) ◽  
Author(s):  
Farastuk Bozorgmehr ◽  
Adriane Hommertgen ◽  
Johannes Krisam ◽  
Felix Lasitschka ◽  
Jonas Kuon ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Response Rate ◽  
Objective Response ◽  
Palliative Radiotherapy ◽  
Progression Free Survival ◽  
Small Cell ◽  
Photon Radiation ◽  
Small Cell Lung ◽  
Free Survival ◽  
Recist 1.1

Abstract Background Hypofractionated palliative radiotherapy for metastatic lung cancer patients is frequently used in order to ease pain, to increase bone stability, to treat local mass effects, or to prolong progression-free survival at critical sites. Recently introduced, immunotherapy for patients with non-squamous non-small cell lung carcinoma (NSCLC) has significantly improved outcome in this cohort. Preclinical and early clinical data suggest that the combination of photon radiation with programmed death-1 (PD-1) targeting immunotherapies may promote a strong and durable immune response against tumor manifestations both within and beyond radiation targets. Methods/design In the present prospective, two-group, non-randomized, open-label phase II trial, 130 patients with stage IV non-squamous NSCLC in 2nd-line or 3rd-line treatment will be included. 65 patients with a clinical indication for palliative radiotherapy to non-cerebral/non-pulmonary metastatic sites will receive 240 mg nivolumab followed by palliative radiotherapy with 5 × 4 Gray (Gy) = 20 Gy photon radiation, which will be initiated within 72 h after first nivolumab administration (Group A). 65 patients without an indication for radiotherapy will only receive nivolumab (Group B). Nivolumab will be further administered every two weeks in both groups and will be continued until progression and loss of clinical benefit or until occurrence of limiting toxicities. The primary endpoint will be the objective response rate (ORR) according to response evaluation criteria in solid tumors (RECIST) 1.1. Secondary endpoints will be progression-free survival (PFS) according to RECIST 1.1, overall survival, descriptive subgroup analyses according to PD-L1 expression, toxicity and quality of life. Since response patterns following immunotherapies differ from those after conventional cytostatic agents, both objective response rate and progression-free survival will additionally be assessed according to immune-related RECIST (irRECIST) criteria. Discussion The FORCE study will prospectively investigate response rates, progression-free and overall survival (OS), and toxicity of nivolumab with and without hypofractionated palliative radiotherapy in a group of 130 patients with metastatic non-small cell lung cancer (non-squamous histology) in 2nd-line or 3rd-line treatment. This trial will contribute prospective data to the repeatedly published observation that the combination of hypofractionated photon radiotherapy and medical immunotherapy is not only safe but will also promote antitumoral immune responses. Trial registration Clinicaltrials.gov identifier: NCT03044626 (Date of initial registration: 05 January 2017). Eudra-CT Number: 2015–005741-31 (Date of initial registration: 18 December 2015).

A phase II, multicenter study of encorafenib/binimetinib followed by a rational triple-combination after progression in patients with advanced BRAF V600-mutated melanoma (LOGIC2).

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 10022-10022 ◽  
Author(s):  
Reinhard Dummer ◽  
Shahneen Kaur Sandhu ◽  
Wilson H. Miller ◽  
Marcus O. Butler ◽  
Christian U. Blank ◽  
...  
Keyword(s):  
Objective Response ◽  
Safety Data ◽  
Progression Free Survival ◽  
Genetic Alterations ◽  
Tumor Evolution ◽  
Free Survival ◽  
Group A ◽  
The Individual ◽  
Bayesian Logistic Regression ◽  
Gene Alterations

10022 Background: LOGIC2 evaluates the benefit of a 3rd agent added to encorafenib (enco)/binimetinib (bini), selected at progression based on the genetic tumor evolution. Methods: In part I/run-In, pts were treated with enco/bini until disease progression (as defined per RECIST v1.1). Foundation One NGS was applied on a baseline sample and on a PD sample. Based on the genetic evolution between the biopsy at inclusion (bxI) and at progression (bxPD) and clinical considerations, pts entered part II and received one of four 3rd agent additions to enco/bini combinations: A. LEE011 (CDK4/6 inhibitor), B. BKM120 (PI3K inhibitor), C. INC280 (c-Met inhibitor), or D. BGJ398 (FGFR inhibitor). An adaptive Bayesian logistic regression model (BLRM) guided by the escalation with overdose control (EWOC) principle was used to make dose escalation decisions. Assessments include objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), and safety. Data cutoff for this analysis was May 12, 2019. Data is as is. Part 1 of study is ongoing. Part 2 of study is closed to enrollment. Results: 58 pts enrolled into part II (group A=38; B=6; C=13; D=1). 29 pts were assigned to treatment based on bxPD results (Table). In groups A, B, and C, the confirmed ORR was 5.3%, 0%, and 0%, and the DCR was 26.3%, 16.7%, and 15.4%, with median PFS of 2.1, 1.6, and 2.2 months, respectively. Safety was consistent with known profiles of the individual agents. Conclusions: Triple therapy is feasible when a 3rd agent is added to enco/bini at progression based on genetic alterations, although activity observed was low. Further exploration to identify patterns of resistance susceptible to the addition of a 3rd agent is needed. Gene alterations for enrollment into part 2. Clinical trial information: NCT02159066. [Table: see text]

Treatment of ALK-Positive Non–Small Cell Lung Cancer

2012 ◽  
Vol 136 (10) ◽  
pp. 1201-1204 ◽  
Author(s):  
Yung-Jue Bang
Keyword(s):  
Lung Cancer ◽  
Phase I ◽  
Phase Ii Study ◽  
Objective Response ◽  
Progression Free Survival ◽  
Small Cell ◽  
Second Line ◽  
Small Cell Lung ◽  
Free Survival ◽  
Alk Positive

Crizotinib (Xalkori), the first inhibitor of both anaplastic lymphoma kinase (ALK) and c-Met receptor kinases, has been approved in the United States, Korea, and other countries for the treatment of ALK-positive non–small cell lung cancer (NSCLC). This approval came within just 4 years of the discovery of rearrangements in the ALK gene in a subset of patients with NSCLC. Oral crizotinib 250 mg twice daily showed excellent efficacy in patients with advanced ALK-positive NSCLC, with objective response rates of 61% and 51% in ongoing phase I and II studies, respectively. Objective response rates of current standard, single-agent, second-line therapies are less than 10%. Median progression-free survival was 10 months (95% confidence interval, 8.2–14.7) in the phase I study expanded cohort and has yet to be reached in the phase II study; progression-free survival with current therapies is less than 3 months. Crizotinib was well tolerated; grade 1/2 gastrointestinal toxicity and visual disturbances were the most common adverse events. Patients in the phase II study reported improvements in fatigue, dyspnea, and cough, based on quality of life assessments. Phase III studies investigating crizotinib for the first- and second-line treatment of advanced ALK-positive NSCLC, versus current standards of care, are ongoing. Crizotinib represents a new standard of care for patients with ALK-positive NSCLC and highlights the importance of the role of the pathologist, as molecular profiling becomes a part of initial workups for newly diagnosed patients with NSCLC. This approach will ensure effective individualized treatment for patients with NSCLC.

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