Reduced Response Rate of Necrotic Brain Metastases to Radiosurgery

1999 ◽  
pp. 240-246
Author(s):  
M. Kocher ◽  
J. Voges ◽  
H. Treuer ◽  
V. Sturm ◽  
R.P. M�ller
Keyword(s):  
Brain Metastases ◽  
Response Rate

Extrapulmonary Small Cell Cancer: A New Insight into a Rare Disease

Oncology ◽  
2021 ◽  
pp. 1-7
Author(s):  
Leora Brazg Ferro ◽  
Ido Wolf ◽  
Shira Peleg Hasson ◽  
Inbal Golomb ◽  
Ester Osher ◽  
...  
Keyword(s):  
Brain Metastases ◽  
Response Rate ◽  
Medical Center ◽  
Cell Cancer ◽  
Small Cell ◽  
Ki 67 ◽  
Small Cell Cancer ◽  
Pathological Characteristics ◽  
Results Of Treatment

<b><i>Introduction:</i></b> Extrapulmonary small-cell cancer (EPSCC) is a relatively rare malignancy. The management of EPSCC is usually extrapolated from small-cell lung cancer (SCLC). In spite of the morphological similarity of the 2 malignancies, there are many differences in clinical features, prognosis, and recommendations of treatment of these disorders. The data on the correlation of clinical-pathological characteristics of EPSCC and treatment results is scarce. <b><i>Materials and Methods:</i></b> This retrospective analysis of 41 consecutively treated patients diagnosed with EPSCC in 2015–2018 was performed in a tertiary medical center. The correlation between the clinical and pathological characteristics and the treatment outcome (response rate, disease-free interval, and overall medial survival) was done using the standard statistics, Kaplan-Meier method, and multivariate analyses. The stratification was done on the stage of the disease, Ki-67 proliferative index, the location of the tumor, and smoking. <b><i>Results:</i></b> Forty-one patients were included with a median age of 66.3 years. The most common primary site was the gastrointestinal tract (28, 68.3%) including the pancreas. The most common distant metastasis site was the liver (23, 56.1%). Only 2 patients (4.9%) had brain metastases. Unlike in SCLC, most patients did not have any history of smoking (23, 56.1%). Nineteen patients with metastatic disease received systemic treatment, mostly cisplatin-based chemotherapy, with a response rate of 57.9%. The results of treatment were significantly better in patients with disseminated EPSCC with Ki-67 &#x3c;55%, while its role in limited disease was nonsignificant. <b><i>Discussion:</i></b> The results of our study show the unique entity of EPSCC. The rarity of brain metastases proves that prophylactic brain irradiation should not be recommended in practice. The provocative idea of prophylactic liver irradiation in limited-stage EPSCC of gastrointestinal origin can be evaluated in future studies. The predictive role of Ki-67 is important in metastatic EPSCC. There is probably no role of smoking in developing EPSCC.

Combination of trastuzumab, pertuzumab and docetaxel in patients with advanced non-small cell lung cancer (NSCLC) harboring HER2 mutation: Final results from the IFCT-1703 R2D2 trial.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 9015-9015
Author(s):  
Julien Mazieres ◽  
Claire Lafitte ◽  
Charles Ricordel ◽  
Laurent Greillier ◽  
Jean-Louis Pujol ◽  
...  
Keyword(s):  
Brain Metastases ◽  
Overall Response Rate ◽  
Advanced Nsclc ◽  
Response Rate ◽  
Left Ventricular ◽  
Left Ventricular Ejection ◽  
Loading Dose ◽  
Overall Response ◽  
Grade 3 ◽  
Exon 20

9015 Background: Human epidermal growth factor receptor 2 ( HER2) exon 20 insertions and mutations are oncogenic drivers found in 1-2% of NSCLC. However, there are no approved therapies for these patients. Many studies suggest that the use of HER2 inhibitors developed for breast cancer patients might be of interest in this setting. The aim of this trial was to prospectively evaluate the interest of a combination of two antibodies against HER2 (trastuzumab and pertuzumab) with docetaxel. Methods: IFCT-1703 R2D2 trial is a multicenter, non-randomized phase 2 study with a two-stage design, a power of 90% and an alpha risk at 5% (one-sided). HER2 mutational status was assessed locally in certified molecular genetic centers. Main other inclusion criteria were advanced NSCLC, progression after ≥ 1 platinum-based chemotherapy, asymptomatic brain metastases, left ventricular ejection fraction (LVEF) ≥ 50%, and PS 0-2. Patients were treated every 3 weeks with pertuzumab at a loading dose of 840 mg, and 420 mg thereafter; plus trastuzumab at a loading dose of 8 mg/kg and 6 mg/kg thereafter; and docetaxel at 75 mg/m². Treatment was given until toxicity or disease progression. The primary outcome was overall response rate (ORR). Other endpoints included duration of response, progression-free survival and safety. NCT number: NCT03845270. Results: From May 2019 to October 2020, 45 patients were enrolled in 17 centers and received study treatment. Median age was 64.5 years (range 31–84), 72% females, 35% smokers, 100% non-squamous histology and 15% with ECOG PS 2. 31.1% patients had brain metastases. PD-L1 was expressed ≥ 1% and ≥ 50% in 36% and 7% of the patients, respectively. No other oncogene driver was found associated with HER2 exon 20 mutation. With a median follow-up of 12 months, 44 (98%) patients were evaluable for the primary endpoint. Overall response rate was 29% (n = 13), stable disease 56% (n = 26). Median PFS was 6.8 months (95% CI[4.0-8.5]). Median duration of treatment in patients with confirmed response (n = 13) was 10 months (95% CI[2.7-14.9]). At the time of data cut-off, 15 patients (33%) were still under treatment. Grade 3/4 treatment-related adverse events (AEs) were observed in 64% of patients. No patient experienced treatment discontinuation because of toxicity. One sudden death was possibly related to treatment. Most frequent grade ≥ 3 AEs were neutropenia (33%), diarrhea (13%) and anaemia (9%). Grade 1/2 dyspnea was observed in 3 (6.7%) patients. No ILD were reported. Variation LVEF was -1.72% on average (min: -18 %; max: 10 %). Conclusions: The triplet trastuzumab, pertuzumab and docetaxel is feasible and active in HER2 pretreated advanced NSCLC. These results confirm the activity of HER2 antibodies-based strategy which should be considered in these patients. Clinical trial information: NCT03845270.

Phase II Randomized Trial of Temozolomide and Concurrent Radiotherapy in Patients With Brain Metastases

2002 ◽  
Vol 20 (17) ◽  
pp. 3644-3650 ◽  
Author(s):  
D. Antonadou ◽  
M. Paraskevaidis ◽  
G. Sarris ◽  
N. Coliarakis ◽  
I. Economou ◽  
...  
Keyword(s):  
Brain Metastases ◽  
Randomized Trial ◽  
Response Rate ◽  
External Beam Radiotherapy ◽  
Objective Response ◽  
Complete Response ◽  
Hematologic Toxicity ◽  
Neurologic Symptom ◽  
Symptom Evaluation ◽  
Radiotherapy Alone

PURPOSE: To determine the efficacy, tolerability, and safety of concurrent temozolomide and radiotherapy in patients with previously untreated brain metastases. PATIENTS AND METHODS: Fifty-two patients with brain metastases from solid tumors were randomized to oral temozolomide (75 mg/m2/d) concurrent with 40-Gy fractionated conventional external-beam radiotherapy (2 Gy, 5 d/wk) for 4 weeks versus 40-Gy radiotherapy alone. The group receiving temozolomide and radiotherapy continued temozolomide therapy (200 mg/m2/d) for 5 days every 28 days for an additional six cycles. The primary end points were radiologic response and neurologic symptom evaluation. RESULTS: The objective response rate was significantly (P = .017) improved in patients receiving temozolomide and radiotherapy versus radiotherapy alone. Among 24 patients assessable for response in the temozolomide group, 23 (96%) of 24 responded, including nine (38%) patients with a complete response and 14 (58%) patients with a partial response. With radiotherapy alone, 14 (67%) of 21 assessable patients responded, including seven (33%) complete responses and seven (33%) partial responses. There was marked neurologic improvement in the group receiving temozolomide, and the proportion of patients requiring corticosteroids 2 months after treatment was lower in the temozolomide group compared with radiotherapy alone (67% v 91%, respectively). Daily temozolomide concurrent with radiotherapy was generally well tolerated; however, grade ≥ 2 nausea (48% v 13%, P = .13) and vomiting (32% v 0%, P = .004) were significantly increased in the temozolomide group. Hematologic toxicity was predictable and reversible. CONCLUSION: Temozolomide is safe, and a significant improvement in response rate was observed when administered in combination with radiotherapy in patients with previously untreated brain metastases. A larger randomized trial is warranted to verify these results.

Treatment of Brain Metastases of Small-Cell Lung Cancer: Comparing Teniposide and Teniposide With Whole-Brain Radiotherapy—A Phase III Study of the European Organization for the Research and Treatment of Cancer Lung Cancer Cooperative Group

2000 ◽  
Vol 18 (19) ◽  
pp. 3400-3408 ◽  
Author(s):  
Pieter E. Postmus ◽  
Hanny Haaxma-Reiche ◽  
Egbert F. Smit ◽  
Harry J. M. Groen ◽  
Hanna Karnicka ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Brain Metastases ◽  
Response Rate ◽  
Whole Brain Radiotherapy ◽  
Phase Iii ◽  
Time To Progression ◽  
Brain Radiotherapy ◽  
Combined Modality ◽  
Phase Iii Study ◽  
The Brain

PURPOSE: Approximately 60% of patients with small-cell lung cancer (SCLC) develop brain metastases. Whole-brain radiotherapy (WBRT) gives symptomatic improvement in more than 50% of these patients. Because brain metastases are a sign of systemic progression, and chemotherapy was found to be effective as well, it becomes questionable whether WBRT is the only appropriate therapy in this situation. PATIENTS AND METHODS: In a phase III study, SCLC patients with brain metastases were randomized to receive teniposide with or without WBRT. Teniposide 120 mg/m2 was given intravenously three times a week, every 3 weeks. WBRT (10 fractions of 3 Gy) had to start within 3 weeks from the start of chemotherapy. Response was measured clinically and by computed tomography of the brain. RESULTS: One hundred twenty eligible patients were randomized. A 57% response rate was seen in the combined-modality arm (95% confidence interval [CI], 43% to 69%), and a 22% response rate was seen in the teniposide-alone arm (95% CI, 12% to 34%) (P < .001). Time to progression in the brain was longer in the combined-modality group (P = .005). Clinical response and response outside the brain were not different. The median survival time was 3.5 months in the combined-modality arm and 3.2 months in the teniposide-alone arm. Overall survival in both groups was not different (P = .087). CONCLUSION: Adding WBRT to teniposide results in a much higher response rate of brain metastases and in a longer time to progression of brain metastases than teniposide alone. Survival was poor in both groups and not significantly different.

scholarly journals Response rate of patients with baseline brain metastases from recently diagnosed non‐small cell lung cancer receiving radiotherapy according to EGFR , ALK and KRAS mutation status

2020 ◽  
Vol 11 (4) ◽  
pp. 1026-1037 ◽  
Author(s):  
Oscar Arrieta ◽  
Laura‐Alejandra Ramírez‐Tirado ◽  
Enrique Caballé‐Perez ◽  
Alberto Mejia‐Perez ◽  
Zyanya Lucia Zatarain‐Barrón ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Brain Metastases ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Kras Mutation ◽  
Response Rate ◽  
Small Cell ◽  
Small Cell Lung ◽  
Mutation Status ◽  
Kras Mutation Status

Low protracted dose of temozolomide (TMZ) and concurrent radiotherapy for brain metastasis of solid tumors

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 12525-12525
Author(s):  
R. Addeo ◽  
V. Faiola ◽  
G. Cennamo ◽  
R. Guarrasi ◽  
L. Montella ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Brain Metastasis ◽  
Brain Metastases ◽  
Overall Response Rate ◽  
Response Rate ◽  
Whole Brain Radiotherapy ◽  
Primary Brain Tumours ◽  
Brain Radiotherapy ◽  
Dna Alkyltransferase ◽  
Grade 3

12525 Background. Whole brain radiotherapy (WBRT) remains the mainstay of therapy for brain metastasis of solid tumours not amenable to surgical resection. Chemotherapy with temozolomide (TMZ) has emerged as an alterative approach for recurrent brain metastases. It has been already used alone or in combination with radiotherapy in the treatment of primary brain tumours. Protracted administration of TMZ, even at relatively low daily doses, leads to significant and prolonged depletion of enzyme O6-alkylguaninae-DNA alkyltransferase (AGAT) activity, with may enhance the antitumor activity of the agent. Methods. Patients with histologically or cytologically confirmed breast cancer and NSCLC and inoperable brain metastasis were eligible for the study .We have treated 29 consecutive patients (16 F and 13 M, mean age: 55, range 46–76) affected by brain metastases ( 16 non-small-cell lung cancer and 13 breast cancer) with WBRT at 3 Gy/day administered over a two-week period (on wks 1–2), total dose 30 Gy, and an induction with TMZ 50 mg/m2/day during this period, following TMZ 50mg/m2 fractionated in 21 days every 28 days, for up to 12 cycles. Pts who received at least one cycle of TMZ were assessable for response. Results. Twenty-four patients were subjected to the induction therapy and 124 cycles were performed. TMZ was generally well tolerated, and the main toxicities seen were hematologic. The toxicities were generally between grade 1 or 2 in severity although two patients had grade 3 events. Two CR, in patients with breast cancer and NSCLC. Nine partial responses were recorded in 5/11 patients with breast cancer, 4/13 patients with NSCLC, while a stable disease was achieved in other 5 patients. Eight patients showed progressive BM growth during the treatment. The overall response rate was 45.5% (C.I. 38.7–56.9%), while the disease control rate was 77% (C.I. 61.7–82.4%). At the present, the overall survival at 12 months was 64%. Conclusions. We developed a new regimen based on a different strategy: the utilization of a more intensive TMZ dosing schedule that would permit the concomitant use of a second cytotoxic agent on the primary cancer. Final data analysis will be presented. The schedule was safe and well tolerated and has suggested an encouraging activity in brain metastases. No significant financial relationships to disclose.

Phase II trial of oxaliplatin, pemetrexed, and bevacizumab in previously-treated advanced non-small cell lung cancer (NSCLC)

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 7700-7700 ◽  
Author(s):  
R. S. Heist ◽  
P. Fidias ◽  
M. Huberman ◽  
J. Temel ◽  
L. Sequist ◽  
...  
Keyword(s):  
Brain Metastases ◽  
Phase Ii ◽  
Response Rate ◽  
Phase Ii Trial ◽  
Single Agent ◽  
Sensory Neuropathy ◽  
Large Cell ◽  
Study Patient ◽  
Eligibility Criteria ◽  
Grade Iii

7700 Background: Single agent chemotherapy is standard for second and third line therapy of NSCLC. Combination therapy has to date not proven to be superior to single agents –often adding additional toxicity without any additional efficacy. We investigated whether the combination of oxaliplatin, pemetrexed, and bevacizumab was an active and tolerable regimen in the pre-treated advanced NSCLC setting. Methods: In this two-stage phase II trial, patients received pemetrexed (500 mg/m2), oxaliplatin (120 mg/m2), and bevacizumab (15 mg/kg) on day 1 of every 21 day cycle, for a total of 6 cycles or until disease progression. Eligibility criteria included PS 0–1, non-squamous histology, and at least one prior chemotherapy regimen. Patients with treated brain metastases were allowed on this trial. The primary endpoint was response rate, with secondary endpoints of TTP, PFS, and OS. Results: 36 patients were enrolled on this study. Patient characteristics for 32 for which data is available were: 16 (50%) women, 16 (50%) men, 26 (81%) adenocarcinoma, 6 (19%) large cell or NSCLC, 6 (19%) treated brain metastases. Of the 31 patients evaluable for tumor response, 0 had CR, 8 (25%) had PR, 14 (44%) had SD, and 9 (28%) had PD. One patient experienced Grade V hemoptysis after cycle 2 before restaging. Nine patients experienced a Grade III/IV serious adverse event. These Grade III/IV toxicities included: cardiac ischemia (1), sensory neuropathy (1), dyspnea (1), anemia (1), constipation (1), fatigue (1), colitis (1), face pain (1), hyperglycemia (1), elevated ALT (1). Among the 6 patients with treated brain metastases, there was 1 PR, 2 SD, 2 PD, and one patient with Grade V hemoptysis whose response could not be assessed; there were no brain hemorrhage events. Data for PFS and OS are preliminary; estimated median PFS is 5.8 months (95% CI 3.8 - 8.9 mo), and estimated OS is 10.9 mo (95% CI 6.4 - 20 mo). Updated data will be presented at the time of the meeting. Conclusions: This data suggests that the combination of pemetrexed, oxaliplatin, and bevacizumab is tolerable and has a promising response rate. Updated data will be presented at the meeting. No significant financial relationships to disclose.

Efficacy and safety of bevacizumab in nonsquamous non-small cell lung cancer with brain metastases.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e19134-e19134
Author(s):  
Masao Ichiki ◽  
Tsukasa Yoshida ◽  
Masayuki Nakamura ◽  
Tomomi Kumano ◽  
Tomoaki Hoshino
Keyword(s):  
Brain Metastases ◽  
Response Rate ◽  
Concurrent Chemotherapy ◽  
Bleeding Events ◽  
Mutation Status ◽  
Prior Therapy ◽  
Mri Scans ◽  
Previously Treated ◽  
Grade 3 ◽  
Extracranial Metastases

e19134 Background: Patients (pts) with brain metastases were excluded from bevacizumab (Bev) therapy due to a case of fatal cerebral hemorrhage in 1997. However, several trials showed the safety of Bev in pts with inactive (previously treated or asymptomatic) brain metastases, and Bev therapy was recently permitted as practical care for brain metastases in Japan. Methods: We retrospectively identified pts treated with Bev for inactive brain metastases from NSCLC. CT or MRI scans performed at least 6 weeks after Bev therapy were assessed for response. Results: There were 17 pts. All pts had adenocarcinoma. Median age was 66 (range 57-74), male/female= 8/9, PS0/1/2= 3/10/4, 1st-/2nd-/3rd-/4th-line chemotherapy with Bev = 8/4/4/1, EGFR mutation status; mutated/wild type/unknown=8/7/2; concurrent chemotherapy with Bev: amrubicin (1), pemtrexed (2), cisplatin (carboplatin) + pemetrexed (10), carboplatin + paclitaxel (3), cisplatin + gemcitabine (1); prior chemotherapy: gefitinib (6), erlotinib (3), docetaxel (1), carboplatin + paclitaxel (2), cisplatin + pemetrexed (2), pemetrexed (1); prior therapy for brain metastases: surgery (1), surgery + WBRT (2),WBRT (8), SRS (4), none (2). In 14 pts with evaluable target brain metastases, the response rate for intracranial metastases was 78.6% (95% CI, 49.2-95.4%), and in 15 pts with evaluable target lesions except brain metastases, the response rate for extracranial metastases was 40.0% (95% CI, 16.3-67.7%). Serious toxicities (grade 3/4): hypertension (2/0), proteinuria (0/-). There were 2 bleeding events: one was grade 1 intracraninal hemorrhage, the other was grade 1 bronchopulumonary hemorrhage. Conclusions: Chemotherapy+Bev is effective for pts with inactive brain metastases and is a well-tolerated regimen with a favorable toxicity profile. The updated data including PFS and OS will be presented at the Annual Meeting.

Pulse-continuous dose erlotinib as initial targeted therapy for patients with EGFR-mutant lung cancers with untreated brain metastases.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 9039-9039 ◽  
Author(s):  
Mark G. Kris ◽  
Kathryn Cecilia Arbour ◽  
Gregory J. Riely ◽  
Ai Ni ◽  
Kathryn Beal ◽  
...  
Keyword(s):  
Brain Metastases ◽  
Response Rate ◽  
Phase 1 ◽  
Progression Free Survival ◽  
Leptomeningeal Metastases ◽  
Phase 1 Study ◽  
Free Survival ◽  
Lung Cancers ◽  
Continuous Dose ◽  
Egfr Mutant

9039 Background: Clarke (Neurooncol 2010) reported responses with intermittent high pulse doses of erlotinib (leading to higher concentrations in CSF) given to patients with EGFR-mutant central nervous system metastases developing on standard erlotinib doses. In a phase 1 study of pulse-continuous dose erlotinib, no patient developed progression in existing or new brain or leptomeningeal metastases (Yu Ann Oncol 2016). This phase 2 trial tested pulse-continuous dose erlotinib in patients with lung cancers with EGFRmutations with brain metastases. Methods: Patients had no prior EGFR TKI or radiation to the brain and at least 1 target brain metastasis. All received initial daily "pulse" doses of erlotinib 1200 mg days 1&2 and "continuous" 50 mg doses days 3-7 (doses and schedule from the Yu Phase 1 study), weekly until progression. The co-primary endpoints were overall and brain metastasis response by RECIST 1.1. Results: We enrolled 19 patients with EGFR-mutant lung cancers: median age 61yrs (range 45-80), 74% women, 95% Karnofsky PS ≥80%, 1 leptomeningeal disease, 33% prior pemetrexed-based chemotherapy. The median size of target brain metastases was 13 mm (range 10-19 mm). 32% were on dexamethasone for cerebral edema. The partial response rate overall was 74% (95% CI 51-89%) and also 74% in brain metastases. Of 10 patients with progression, 9/10 occurred in non-brain sites (4 EGFRT790M, 1 with progression in brain as well), 1 with leptomeningeal. The median progression free survival was 10 mo (range 7-NR mo). Pulse doses were reduced in 68% (median delivered pulse dose 1050 mg days 1&2, range 600-1200 mg). Incidences of any gradeof rash and diarrhea were 84% and 63% respectively. There were no grade 4 or 5 toxicities. Conclusions: Pulse-continuous dose erlotinib alone controlled brain and leptomeningeal metastases in 89% (95% CI 67-98%) of patients with EGFR-mutant lung cancers with central nervous system spread pretreatment, with an overall response rate of 74% and progression free survival and rates of rash and diarrhea comparable to series with erlotinib 150 mg daily. Supported by Astellas, CA 129243, CA 008748. NCT01967095 Clinical trial information: NCT01967095.

Icotinib and whole brain radiotherapy (WBRT) for patients with brain metastases from non-small cell lung cancer (NSCLC): Preliminary results of a phase II study.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e19073-e19073
Author(s):  
Fan Yun ◽  
Zhiyu Huang ◽  
Lei Gong ◽  
Haifeng Yu ◽  
Haiyan Yang ◽  
...  
Keyword(s):  
Brain Metastases ◽  
Phase Ii ◽  
Kinase Inhibitors ◽  
Advanced Nsclc ◽  
Response Rate ◽  
Phase Ii Study ◽  
Whole Brain Radiotherapy ◽  
Phase Iii ◽  
Double Blind ◽  
The Mean

e19073 Background: Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs), such as gefitinib and erlotinib, have shown efficacy in advanced NSCLC with brain metastases (BM). Icotinib is a new EGFR-TKI. A randomized, double blind phase III trial proved that icotinib was non-inferior to gefitinib in advanced NSCLC. We have conducted a phase II study to evaluate the efficacy and safety of icotinib in combination with WBRT in Chinese NSCLC patients with BM. Methods: From January 2012 to January 2013, 20 patients aged 18-75 years with ECOG PS 0-2 and BM from NSCLC,were recruited regardless of EGFR status. The treatment comprised icotinib 125mg, TID concurrently with WBRT (30Gy/10f/2w). CSF and plasma samples were collected at the same time from 10 patients at least 5 days after icotinib treatment. The concentrations of icotinib in the CSF and plasma were measured by high performance liquid chromatography coupled with tandem mass spectrometry. The primary end point was progression-free survival (PFS) . Additional end points were response rate, safety and CSF concentrations of icotinib. Results: The median PFS was 7.3 months [95% confidence interval (CI) 4. 2-9.8]. Patients with EGFR mutation-positive disease had significantly longer median PFS versus EGFR wild-type disease [NR versus 4.2 months (95% CI 2.9-5.1); P = 0.000]. The CNS response rates were 25% complete response (n=5), 55% partial response (n= 11), 15% stable disease (n=3), and 5% progressive disease (n =1). The overall CNS response rate was 80% (n = 16). The most common adverse events were rash (40.0%), diarrhea (15.0%),nausea (45.0%), vomiting (20.0%), headache (35.0%)and fatigue (45.0%). And no patient experienced grade ≥ 3 toxicity. The mean plasma and CSF concentrations of icotinib were 936.47 ± 503.80 and 8.93 ± 8.01 ng/ml, respectively, and the mean ratio of CSF-plasma concentration was 1.04% ± 0.95. Conclusions: Icotinib was well tolerated and showed promising activity in combination with WBRT in patients with BM from NSCLC. The concentrations of icotinib in CSF were low. Further randomized trials are warranted. Clinical trial information: NCT01514877.

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