This study was designed to investigate the correlation factors for occurrence and progression-free survival of patients with cavitating lung cancer.We collected the clinical data of 947 lung cancer patients. Tumor cavitation was observed in 51 patients at baseline and in 23 patients after treatment, while was not discovered in other 873 patients. Multifactor logistic regression was performed to analyze the correlation factors for occurrence. The independent predictors of PFS were analyzed with Cox proportional regression. Survival curves were constructed with the Kaplan-Meier product limit method and compared using the log-rank test.In the 947 cases, the proportion of cases with baseline cavitation was 5.4% and the incidence of cavitation after treatment was 2.6%. Multivariate logistic regression analysis revealed that the occurrence of baseline cavitation is related to age, history of diabetes, history of drinking, pathologic types, tumor location, tumor diameter and distant metastasis (P < 0.05). Multifactor logistic regression analysis revealed that the occurrence of post-therapeutic cavitation is related to sex, pathologic types and tumor diameter (P < 0.05).The median PFS of patients with baseline cavitation (7.3 months) was significantly longer than the cases without it (5.2 months) (P = 0.002). While there was no significant difference between the median PFS of patients with post-therapeutic cavitation and patients without it (5.1 months vs. 5.3 months, P = 0.060). Cox proportional regression analysis revealed that cyfra21-1 is related to PFS of patients with baseline cavitaion (P < 0.05) and smoking history is related to PFS of patients with post-therapeutic cavitaion (P < 0.05).Patients with baseline and post-therapeutic cavitation present different clinical features and progression-free survivals. The PFS of patients with baseline cavitation is longer than that of the cases without it. On the contrary, PFS of patients with post-therapeutic cavitation is shorter than the patients without it.
5518 Background: A Phase I trial has been completed to examine the safety and feasibility of combining bevacizumab (bev) with radiation and cisplatin in patients with locoregionally advanced head and neck squamous cell carcinoma (LA-HNSCC). We assessed the capacity of bev monotherapy to induce tumor response as measured by functional imaging and biomarker evaluation. We report preliminary clinical outcome as well as correlative imaging and biomarker results. Methods: All patients underwent experimental imaging [FLT-PET (proliferation), CuATSM-PET (hypoxia), DCE-CT scans (flow/perfusion)] and biomarker evaluation prior to bev monotherapy. At three weeks, repeat tumor biopsy and imaging/serum studies were performed. Comprehensive H&N chemoradiation (CRT) was then delivered to 70 Gy in 33 fractions with concurrent weekly cisplatin at 30 mg/m2 and Q3 week bev (wks 1, 4, 7) with dose escalation from 5 to 10 to 15 mg/kg. Results: Between 2007-2010, ten LA-HNSCC pts were enrolled. All had stage IV HNSCC and remain alive (9 NED) with a mean survival of 22.4 months. There have been two recurrences at 15 and 16 months respectively. Nine patients experienced grade 3 toxicity (dysphagia-9, mucositis-7, tumor pain-3, weight loss-4, nausea/vomiting-2), with two cases of grade 4 lymphopenia. No significant bleeding was observed. Tumor proliferation (FLT) following bev monotherapy and at mid-course showed significant reduction (p<0.05). Tumor hypoxia (Cu-ATSM) showed minimal change following bev alone, but showed reduction during CRT. AQUA histology confirmed reduction in VEGFR2 expression from tumor biopsies following bev therapy. Conclusions: The incorporation of bev with comprehensive CRT for LA-HNSCC appears safe and feasible. Several patients manifested tumor regression following administration of bev alone. Three patients experienced pronounced tumor pain early in the treatment course. Experimental imaging and biomarker evaluation demonstrated clear changes following bev alone and during CRT. These findings may afford opportunities to forecast clinical outcome for individual patients and thereby tailor therapy approaches in future clinical trials.
Certain radiographic signs of a treatment response, such as cavitation, changes in density, or tumor change along a short axis, are not considered by Response Evaluation Criteria in Solid Tumors (RECIST). This study evaluates what additional prognostic information can be obtained by including these criteria in tumor assessment.Data of 105 patients were included. Tumor cavitation was observed in 51 patients at baseline. An additional 23 patients developed tumor cavitation during treatment. A change in tumor density was the only radiographic treatment response observed in 22 patients. The only measureable treatment response in nine patients was a decrease along the short axis size of the tumor. Tumor response was assessed using various criteria.In patients with basic tumor cavitation, RECIST1.1 scores accurately predicted differences in progression-free survival (PFS; P = 0.076) while modified (m) RECIST did not (P = 0.550). mRECIST detected a significant difference between PFS in patients with post-therapeutic cavitation with different responses, but no significant difference using RECIST1.1 (P = 0.004 vs. P = 0.477). In patients with only tumor density changes, there was no significant difference in PFS when either RECIST1.1 or density criteria were used (P = 0.419). In patients with a change in size along the tumor's short axis, short axis criteria could predict significant difference in PFS (P = 0.004).RECIST1.1 provides the best assessment of tumor response and prediction of PFS in patients with basic tumor cavitation. mRECIST provides better PFS prognostic information in patients with post-therapeutic cavitation. Short axis criteria provides better PFS prognostic information in patients with changes in the short axis of tumor diameter. Changes in tumor density were not a useful prognostic sign.
4121 Background: Advanced gastric cancer (AGC) remains the second leading cause of cancer death worldwide. We performed a phase II study to evaluate cetuximab combined with XELOX as first-line treatment of metastatic unresectable G or GEJ adenocarcinoma. The aim of this study was to identify molecular predictors of response/survival to XELOX+cetuximab by evaluating germline single nucleotide polymorphisms (SNPs) in genes involved in 5-FU (TYMS, MTHFR) and oxaliplatin (ERCC1, XPD, GSTP1) metabolism and human epidermal receptor signaling (EGF, HER2, COX2, FCgR2A, FCgR3A) to identify patients (pts) that benefit from this regimen. Methods: DNA was extracted from whole blood in 59 of 72 pts (14 XELOX; 58 XELOX+cetuximab). One more evaluable pt needed for complete accrual. The median progression-free survival (PFS) and overall survival (OS) among 68 pts with a minimum of 1-month follow-up were 5.3 and 13.3 months, respectively. SNPs were analyzed by PCR-based protocols and their association with response rate (RR) and OS were analyzed using Fisher’s exact test, Kaplan-Meier curves, and log-rank tests, as appropriate. Results: There was a statistically significant association between the SNPs EGF A+61G rs4444903 and GSTP1 Ile105Val rs1695 and RR: 40 patients with EGF+61 G allele had a 62.5% RR, whereas the 11 patients with the AA genotype had a 27.3% RR (p=0.0477). 22 patients with the Ile genotype of the GSTP1 was 72.7% RR, whereas the 31 patients with Val (AG or GG) had a 38.7% RR (p=0.0248). In addition, there was a statistically significant association been MTHFR A1298C rs1801131 and OS (p=0.044). Pts carrying MTHFR 1298 AA had a longer OS (21.3 months) compared with pts carrying AC or CC (8.7 months). No other significant associations between SNPs and RR or OS were observed. Conclusions: This analysis suggests that the EGF A+16G and GSTP1 SNPs may be predictive markers for RR and MTHFR A1298C may be predictive of OS for pts with G and GEJ adenocarcinoma treated with XELOX+cetuximab. Further evaluation is warranted.
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