Predictors of second- and third-line chemotherapy receipt in stage IV colon cancer Medicare beneficiaries.

2013 ◽  
Vol 31 (4_suppl) ◽  
pp. 588-588
Author(s):  
Emily S Reese ◽  
Ebere Onukwugha ◽  
Nader Hanna ◽  
Brian S. Seal ◽  
C. Daniel Mullins

588 Background: The prognosis for elderly patients with metastatic colon cancer (mCC) is poor with 5-year survival rate of 6 %. There is limited evidence to explain why some elderly mCC patients progress through multiple lines of treatment and others with similar clinical characteristics do not. This study examines the predictors of second- and third-line chemotherapy receipts in Medicare beneficiaries with mCC who initiate treatment. Methods: Using the SEER-Medicare dataset, elderly beneficiaries diagnosed with mCC from 2003-2007, were followed until death or censoring in 2009. Treatment lines were classified in combinations of chemotherapy and biologics. Logistic regression was used to predict receipt of treatment and subsequent treatment. Results: Among 3,266 beneficiaries diagnosed with mCC and initiated therapy, 1,440 progressed to 2nd line treatment and 274 progressed to 3rd line treatment. The strongest predictors of progressing to 2nd line treatment was surgery of the primary tumor site (OR: 2.42, 95% CI: 2.17-2.70) and regional/distal sites (OR: 1.32, 95% CI: 1.14-1.53) and marital status (OR: 1.64, 95% CI: 1.47-1.83). Older beneficiaries (80-84 years (OR: 0.31, 95% CI: 0.26-0.37) and > 85 years (OR: 0.10, 95%CI: 0.08-0.12)) and those with poor performance status indicators (walk aid (OR: 0.46, 95% CI: 0.26-0.82), wheelchair use (OR: 0.43, 95% CI: 0.29-0.64), and use of oxygen (OR: 0.54, 95% CI: 0.41-0.69)) were less likely to proceed to 2nd line treatment. Older age was the biggest predictor of not proceeding to third-line treatment (80-84 years (OR: 0.42, 95% CI: 0.28-0.61) & > 85 years (OR: 0.10, 95%CI: 0.05-0.19)). No variables were statistically significant in predicting receipt of third-line chemotherapy. Conclusions: Surgery of the primary tumor site and of regional/distal sites were the most significant clinical variables predicting whether or not elderly patients proceed to second-line chemotherapy. Sociodemographic variables also predicted receipt of second-line chemotherapy.

2020 ◽  
Author(s):  
Hidejiro Kawahara ◽  
Nobuo Omura ◽  
Tadashi Akiba

Abstract Aim: This study aimed to evaluate a long-term outcome predictor after second-line chemotherapy for unresectable colorectal cancer.Methods: Between 2013 and 2018, sixteen patients (twelve males, four females) with unresectable colorectal cancer who were administered TAS-102 as third-line chemotherapy in our institution were retrospectively enrolled in this study. The mean age was 65.4 (range: 46-79) years. Patients were administered oxaliplatin with oral S-1 (tegafur, gimeracil, oteracil potassium) (SOX) as first-line chemotherapy followed by irinotecan with oral S-1 (IRIS) as second-line chemotherapy.Results: The median survival time after second-line chemotherapy was 19.2 months. Significant differences in mean age, gender, body mass index, primary site of disease, pathology of primary tumor, depth of primary tumor invasion, serum carcinoembryonic antigen (CEA) level, serum carbohydrate antigen 19-9 (CA19-9) level, and recurrence site of disease were not observed between patients with less than one year of survival versus greater than one year of survival. However, neutrophil-lymphocyte ratio (NLR) at the beginning of third-line chemotherapy was the only factor of the ten evaluated that exhibited a significant difference. Primary tumor site (p=0.015) and NLR at the beginning of third-line chemotherapy (p=0.010) were independent contributing factors to predict survival after second-line chemotherapy based on Cox proportional hazards regression.Conclusion: NLR at the beginning of third-line chemotherapy is a useful predictor for unresectable colorectal cancer after second-line chemotherapy.


2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 4591-4591
Author(s):  
Milind M. Javle ◽  
Saeed Sadeghi ◽  
Anthony B. El-Khoueiry ◽  
Lipika Goyal ◽  
Philip Agop Philip ◽  
...  

4591 Background: Cholangiocarcinoma (CCA) is the most common biliary tract malignancy with an estimated incidence of 8,000–10,000 patients/year in the US. Chemotherapy is the most common second-line treatment with reported outcomes in patients with CCA. Response rates of < 10% and median progression-free survival (PFS) times of ~3–4 months have been reported with second-line chemotherapy regimens, including FOLFOX in the ABC-06 trial. Fibroblast growth factor receptor 2 ( FGFR2) fusions occur in 13–17% of CCA and multiple targeted agents are in development for patients with FGFR2 fusions. To date, the outcome of patients with CCA and FGFR2 fusions receiving standard second-line chemotherapy is unknown. Methods: Patients with advanced CCA and FGFR2 fusions after prior treatment with gemcitabine-based chemotherapy were enrolled in a single-arm phase 2 study (NCT02150967) and received the FGFR1–3 selective TKI infigratinib (previously BGJ398) 125 mg orally qd on d1–21, cycles repeated q28 days until unacceptable toxicity, disease progression, investigator discretion, or withdrawal of consent. A retrospective analysis of a subset of patients who received infigratinib as third- or later-line treatment was performed. Investigator-assessed PFS and best overall response (BOR, per RECIST 1.1) following second-line chemotherapy (pre-infigratinib) and third-line or later-line infigratinib were calculated. Results: Of the 71 patients (44 women; median age 53 years) with FGFR2 fusions enrolled at the time of analysis (datacut 8 August 2018), 37 (52%) were included in this retrospective analysis. Median PFS with standard second-line chemotherapy was 4.63 months (95% CI 2.69–7.16) compared with 6.77 months (95% CI 3.94–7.79) for third- and later-line infigratinib. BOR for second-line chemotherapy was 5.4% (95% CI 0.7–18.2) compared with 21.6% for third- and later-line infigratinib (95% CI 9.8–38.2). Conclusions: Outcomes from second-line chemotherapy in patients with CCA and FGFR2 fusions were similar to those reported in the literature for all patients with CCA regardless of genomic status and remain dismal. Infigratinib administered as third- and later-line treatment resulted in a meaningful PFS and ORR benefit in patients with CCA and FGFR2 fusions. Clinical trial information: NCT02150967 .


2019 ◽  
Vol 37 (4_suppl) ◽  
pp. 82-82 ◽  
Author(s):  
Hiroko Hasegawa ◽  
Tetsuya Iwasaki ◽  
Akio Ishihara ◽  
Yuko Sakakibara ◽  
Tomohumi Akasaka ◽  
...  

82 Background: Recently, the proportion of elderly patients (pts) with metastatic gastric cancer (mGC) has increased in Japan. Survival benefits of salvage treatment after second-line chemotherapy (CTX) for mGC were shown in several prospective studies. However, the role of salvage treatment in elderly pts remains controversial. Methods: We reviewed 185 pts with mGC who received palliative CTX aged ≥ 70 years at our institution between April 2007 and March 2018. Eligibility criteria were as follows: PS 0-2, refractory to first-line and second-line CTX. The purpose of this study was to evaluate the clinicopathologic factors that affected overall survival for elderly pts with mGC, univariate and multivariate analyses were performed on the baseline factors at the beginning of third-line CTX. Results: Of all, 71 pts were eligible. Median age was 75 years (71-85). Median progression-free survival (PFS) and overall survival (OS) for third-line CTX were 3.2 and 7.5 months, respectively and an overall response rate and disease control rate were 4.2% and 43.7%, respectively. In univariate analysis, the following four factors were identified to have prognostic significance: performance status (PS) (ECOG 0–1 or 2), serum albumin level (< 3.5 or ≥ 3.5 g/dl), serum LDH level (≤ 240 or > 240 IU/l), PFS under second-line CTX (< 3 or ≥ 3 months). Multivariate analysis found three prognostic factors affecting poor survival following third-line CTX: PS of 2 (hazard ratio (HR) 8.89, 95% confidence interval (CI) 3.99–20.2; P = 0.001), serum LDH level > 240 IU/l (HR 2.75, 95% CI 1.48–5.05; P = 0.002) and median PFS under second-line CTX of < 3 months (HR 1.89, 95% CI 1.01–3.43; P = 0.045). A prognostic index was constructed, dividing pts into low- (0 factor), intermediate- (1-2 risk factors), or high- (3 risk factors) risk groups. Median OS for each group were 12.6, 6.0 and 3.0 months, respectively ( P < 0.001). Conclusions: This analysis suggests that some clinicopathologic factors might be helpful in identifying the subgroup of elderly pts most likely to benefit from third-line CTX for metastatic gastric cancer.


2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e14035-e14035
Author(s):  
C. Daniel Mullins ◽  
Kaloyan A Bikov ◽  
Ebere Onukwugha ◽  
Brian S. Seal ◽  
Nader Hanna

e14035 Background: Stage IV colon cancer (CC4) patients may receive multiple lines of chemotherapy and/or biologics as treatment (TX) to improve survival or quality of life, yet elderly patients generally receive less aggressive cancer TX. Methods: Elderly (65+) SEER-Medicare patients diagnosed with CC4 in 2003-7 were followed through death or 2009 to examine variation across sub-groups in the number of TX lines. TX included 5-fluorouracil and (levo)leucovorin-based (5FU/LV); irinotecan (IRI) and/or oxaliplatin (OX) with/out 5FU/LV; bevacizumab, cetuximab, or panitumumab (MNCLA), alone or in combination with chemotherapy; and other TX. A hierarchy categorized treatments as: 1) IROX (IRI+OX); 2) IRI or OX; 3) 5FU/LV; 4) MNCLA without chemotherapy; and 5) other TX. Gaps in TX or changes from OX or IRI to 5FU/LV were not considered new lines. Results: Of 7,937 elderly CC4 patients, 3,263 (41%) received any TX, while 1,541 (19%) and 570 (7%) received second and third line TX, respectively. Among the TX group, younger (p<0.01), married (51 vs. 42%, p < 0.01) and male (49 vs. 45%, p = 0.02) patients were more likely to go on to second line TX. Medicare buy-in coverage, which generally indicates dual Medicaid-Medicare coverage (42 vs. 48%, p = 0.03), lowered the likelihood of second line TX. Having comorbidities impacted initial TX (CCI=0: 44.5%, CCI=1: 41.9%, CCI=2: 28.4% ; p<0.01) more so than the likelihood of second (CCI=0: 48.6%, CCI=1: 45.9%, CCI=2: 42.4% ; p=0.06) or third (CCI=0: 37.2%, CCI=1: 39.9%, CCI=2: 29.9% ; p=0.09) line TX conditional upon receipt of prior line treatment. There was no significant association between second line TX and race/ethnicity, urbanicity or year of cancer diagnosis. Among those with second line TX, only age (p=0.05) and urbanicity (38 urban vs. 25% non urban, p < 0.01) were significantly associated with higher likelihood of third line TX. Conclusions: Among CC4 patients with TX, married patients and men receive more TX lines, while number of treatment lines decreases with age. Tendency to use less aggressive treatment with elderly CC4 patients, combined with our observed results, suggests that a substantial proportion of elderly CC4 patients receive fewer TX lines than equivalent younger patients.


2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 4082-4082
Author(s):  
Raffaella Vivolo ◽  
Emilio Bria ◽  
Ina Valeria Zurlo ◽  
Maria Bensi ◽  
Emanuela Dell'Aquila ◽  
...  

4082 Background: Right- (R) and left-sided (L) mCRCs exhibit different clinical and molecular features. Several retrospective analyses showed that the survival benefit of anti-EGFR-based tx is limited to RAS/BRAF wt L-sided mCRC pts, which a larger effect in the first-line setting. Few data are available concerning the anti-EGFR efficacy according to primary tumor site in third line. Methods: Pts affected by RAS/BRAF wt mCRC treated with third-line anti-EGFR-based tx or R/T were retrospectively collected. The objective of the analysis was to compare tx activity and efficacy according to tumor site. Primary endpoint was PFS; secondary endpoints were OS and RR. PFS and OS analyses were performed using Kaplan-Meier method, and survival curves were compared using the log-rank test. RR was evaluated according to RECIST criteria and it was compared in the two groups using Fisher’s exact test. Statistical significance was set at p = 0.05 for a bilateral test. Univariate and multivariate analyses for PFS and OS were performed. Results: A total of 76 RAS/BRAF wt mCRC pts, treated with third-line anti-EGFR-based tx or R/T, were enrolled. Of those, 19 (25%) pts had R-sided tumor (9 pts received anti-EGFR tx and 10 pts received R/T) and 57 (75%) pts had L-sided tumor (30 pts received anti-EGFR tx and 27 pts received R/T). As shown in the table, a significant PFS and OS benefit in favor of anti-EGFR tx vs R/T was observed in L-sided pts, while no difference both in PFS and OS was observed in R-sided pts. RR was significantly higher in L-sided pts treated with anti-EGFR vs R/T, no difference was shown in R-sided pts. At the multivariate analysis, tx regimen was indipendently associated with PFS in L-sided pts, but not in R-sided pts. Conclusions: Our study confirmed the results deriving from the retrospective analysis of the phase III study 20020408. Our results demonstrated a different benefit from third-line anti-EGFR tx according to primary tumor site, confirming the role of L-sided tumor in predicting benefit from third-line anti-EGFR vs R/T, while no difference was observed in R-sided tumors. [Table: see text]


2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e16080-e16080
Author(s):  
Ting Deng ◽  
Le Zhang ◽  
Jingjing Duan ◽  
Hongli Li ◽  
Shaohua Ge ◽  
...  

e16080 Background: Patients with advanced gastric or gastro-esophageal junction cancer have poor prognosis after progression on first-line chemotherapy. We investigated to combine second-line chemotherpy with third-line drugs, apatinib and anti-PD-1 antibody in these patients. Methods: This study is a single center, exploratory study in China. Eligible patients are adults with histologically confirmed advanced gastric or GEJ adenocancinoma, who were failure of first-line or second-line chemotherapy. Subjects receive chemotherapy, pacitaxol or iritecan (investigator choice), apatinib 250mg po qd, sintilimab 200mg ivd q3w. Response was assessed every 6 weeks. (RECIST version1.1) Primary endpoint was progression free survival (PFS). Results: Between May 30, 2019 and November 5, 2020, a total of 26 patients were enrolled in this study, and 4 (15.4%) patients were failure of second-line chemotherapy. There were 21 males and 5 females, and the median age was 61. The total number of treatment cycles was 140 and the median number was 5.5. Among 24 patients who were evaluated, partial response (PR) was obtained in 12 cases, stable disease (SD) in 8 cases and progressive disease (PD) in 4 cases. Objective response rate was 50.0%,and disease control rate was 83.3%. The median PFS was 7.06 months (95% CI 5.52-8.60), and the median overal survival has not yet been reached. The most common adverse events (AE) were leukopenia (61.5%), anemia (57.7%), neutropenia (53.8%), proteinuria (42.3%), alopecia (42.3%), hypothyroidism (38.5%), elevated alanine aminotransferase (34.6%), elevated aspartate aminotransferase (34.6%) and elevated alkaline phosphatase (34.6%), but most of them were grade 1 or 2, and the most common grade 3 or 4 treatment-related adverse events was neutropenia (11.5%). Conclusions: Chemotherapy, plus apatinib and sintilimab demonstrated promising activity and manageable safety profile as second- even third-line treatment in advanced gastric or GEJ cancer. Demographics and baseline characteristics.[Table: see text]


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