scholarly journals Cisplatin and Irinotecan as First-Line Chemotherapy for Previously Untreated Metastatic Thymic Carcinoma: Updated Analysis

2022 ◽  
Vol 11 ◽  
Author(s):  
Akito Fukuda ◽  
Yusuke Okuma ◽  
Taiki Hakosaki ◽  
Kie Mirokuji ◽  
Makiko Yomota ◽  
...  
Keyword(s):  
Disease Control ◽  
Thymic Carcinoma ◽  
Response Rate ◽  
Group Performance ◽  
Disease Control Rate ◽  
Hematological Toxicity ◽  
First Line ◽  
Platinum Based Chemotherapy ◽  
Grade 3 ◽  
Line Chemotherapy

Platinum-based chemotherapy is the de facto standard treatment for metastatic or unresectable thymic carcinoma. The optimal chemotherapy regimen has not yet been determined, including whether this should be combined with a second- or third-generation anti-cancer agent. We retrospectively evaluated the data of patients with metastatic or unresectable thymic carcinoma who were treated with a combination of cisplatin and irinotecan as first-line chemotherapy between 2002 and 2021 (trial registration UMIN000012175). The primary endpoint was response rate according to the RECIST criteria version 1.1. Secondary endpoints were disease control rate, progression-free survival (PFS), overall survival (OS), and toxicity (adverse events). Some patients analyzed in this study were also included in the previous trial, which was terminated early. For this analysis, we included 18 patients with a median age of 56 years and an Eastern Cooperative Oncology Group performance status of 0 or 1. All patients had clinical stage IVa or IVb thymic carcinoma according to the Masaoka-Koga staging system. The response rate was 44% and the disease control rate was 89%. The median PFS was 8.4 months (95% confidence interval (CI): 2.7–11.6 months) and the median OS was 45.6 months (95% CI: 15.7–69.1 months). Grade 3 or worse hematological toxicity was observed in 5 patients and grade 3 or worse non-hematological toxicity was observed in 3 patients. None of the patients developed febrile neutropenia, and no treatment-related deaths occurred. Thus, the combination of cisplatin and irinotecan as first-line chemotherapy for metastatic thymic carcinoma showed efficacy and acceptable toxicity.

Phase II study of irinotecan plus leucovorin and bolus 5 fluorouracil as first or second line chemotherapy in patients with advanced gastric or esophageal-gastric junction adenocarcinoma

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 15128-15128
Author(s):  
M. Gerolymos ◽  
A. Koutras ◽  
E. Kontogeorgou ◽  
G. Iconomou ◽  
G. Vourli ◽  
...  
Keyword(s):  
Disease Control ◽  
Response Rate ◽  
Disease Control Rate ◽  
Survival Duration ◽  
Line Treatment ◽  
Second Line ◽  
First Line ◽  
Second Line Chemotherapy ◽  
Line Chemotherapy ◽  
First Line Treatment

15128 Background: The aim of this study was to evaluate the activity and safety of 5-fluorouracil (5-FU) / leucovorin (LV) and irinotecan as first- or second-line treatment in patients with advanced gastric adenocarcinoma. Methods: Treatment consisted of irinotecan 80 mg/m2 intravenously (i.v.), followed by LV 200 mg/m2 (i.v.) and 5- FU 450 mg/m2 as an i.v. bolus. Treatment was administered weekly for 6 weeks, followed by a 2-week rest period. Results: Thirty-one patients (23 chemo-naïve, 8 chemo-exposed) were enrolled. The overall response rate was 22.6% and the disease control rate was 38.7%. Among the patients who received the regimen as first-line treatment, objective response rate was 30.4% and the disease control rate was 52.1%. However, progression of the disease was recorded in all the patients receiving the combination as second-line chemotherapy. The median time to disease progression (TTP) was 4 months and the median duration of survival was 7 months. The median TTP was 6 months for patients treated with first-line chemotherapy and 2.5 for those who received study treatment as second line. Furthermore, the median survival duration was 8 months and 6 months, respectively. The most frequent grade 4 toxicity was febrile neutropenia. Grade 3 or 4 non-hematological toxicities were rare. There were no treatment-related deaths. Conclusions: The combination of 5-FU/LV and irinotecan as first-line treatment was found to be well tolerated, with efficacy comparable to that of other regimens in advanced gastric cancer. Accordingly, this regimen can be regarded as one of first-line options, particularly in patients who can not tolerate aggressive chemotherapy. No significant financial relationships to disclose.

A phase II study of combination CPT-11 and docetaxel in patients with ovarian carcinoma refractory or resistant to combination paclitaxel and carboplatin

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 15036-15036
Author(s):  
T. Enomoto ◽  
K. Yoshino ◽  
M. Yamasaki ◽  
Y. Nishio ◽  
A. Wakimoto ◽  
...  
Keyword(s):  
Ovarian Carcinoma ◽  
Combination Chemotherapy ◽  
Response Rate ◽  
Phase Ii Study ◽  
First Line ◽  
Good Compliance ◽  
Measurable Disease ◽  
Grade 3 ◽  
Line Chemotherapy ◽  
Carboplatin Auc

15036 Background: To investigate the efficacy and toxicity of combination irinotecan and docetaxel in patients with ovarian carcinoma refractory (not responded) or resistant (relapsed within 6 months after the last chemotherapy) to the first line chemotherapy with combination paclitaxel (175mg/m2) and carboplatin (AUC=5). Methods: 30 refractory patients and 28 resistant patients with measurable disease were treated with combination irinotecan (60 mg/m2) and docetaxel (30 mg/m2) at days 1 and 8 every 3 weeks for more than 2 courses. Results: The average number of courses administered was 2.6 for refractory cases and 3.4 for resistant cases. The average number of courses administered was 2.6 for refractory cases and 3.4 for resistant cases. Using RECIST criteria, 2/28 (7%) resistant cases responded completely, 6/30 (20%) of refractory cases and 6/28 (21%) resistant cases were responded partially. 16/30 refractory cases and 14/28 cases progressed. Grade 3–4 toxicities were leukopenia (31%) neutropenia (36%) thrombocytopenia (8%) and diarrhea (6%). Conclusions: Combination chemotherapy of CPT-11 and Docetaxel at days 1 and 8 every 3 weeks is a regimen with moderate toxicity and good compliance, and shows some response to those patients who are refractory or resistant to the first-line chemotherapy with paclitaxel and carboplatin with a response rate of 20% and 29%, respectively. No significant financial relationships to disclose.

OS05.7.A Absence of severe hematological toxicity during first line treatment predicts low chance on severe toxicity during second line alkylating chemotherapy in glioblastoma

2021 ◽  
Vol 23 (Supplement_2) ◽  
pp. ii8-ii8
Author(s):  
F E L van den Elzen ◽  
N Grun ◽  
J Osinga ◽  
A N van der Vegt ◽  
L de Glopper ◽  
...  
Keyword(s):  
Hematological Toxicity ◽  
Severe Thrombocytopenia ◽  
Severe Toxicity ◽  
Line Treatment ◽  
Second Line ◽  
First Line ◽  
Infiltrative Growth Pattern ◽  
Grade 3 ◽  
Line Chemotherapy ◽  
First Line Treatment

Abstract BACKGROUND Glioblastoma has an infiltrative growth pattern that makes complete resection of the tumor virtually impossible. Sooner or later the tumor progresses, even after aggressive treatment with maximal safe resection, radiotherapy and/or chemotherapy. Hematological toxicity is an important cause of treatment delays during 1st line treatment. How often hematological toxicity occurs during 2nd line treatment is unclear. We explored rates of hematological toxicities in patients treated with temozolomide or lomustine at progression and investigated the association between severe toxicity during 1st and 2nd line treatment. METHODS We studied a retrospective cohort study of adult patients (n=247) with a glioblastoma treated with 2nd line alkylating chemotherapy at the Brain Tumor Center Amsterdam between 2000 and 2020. First line treatment of these patients consisted of a combination of radiotherapy combined with different treatments (80% received temozolomide, 4% PCV, 6% other chemotherapy and 10% radiotherapy only). Second line treatment consisted of temozolomide or lomustine. Mild and severe hematological toxicity were defined according to the CTCAE (version 5.0) criteria as a grade 1&2 and grade ≥3, respectively. We used descriptive statistics to analyze frequencies of hematological toxicity in patients with glioblastoma treated with 2nd line chemotherapy. RESULTS Sixty percent (147/247) of patients treated with 2nd line chemotherapy experienced hematological toxicity (grade 1–4). Considering subtypes of hematological toxicities, more patients experienced hematological toxicity during 2nd line treatment; severe thrombocytopenia occurred most frequently observed (6,1 during 1st line vs. 10,5% during 2nd line treatment), followed by neutropenia (3,6 vs. 6,9%), leukocytopenia (4,0 vs. 5,3%) and anemia (0 vs. 0,8%). Fewer patients treated with 2nd line temozolomide (n=113) experienced mild and severe hematological toxicity than patients treated with 2nd line lomustine (n=134; 46% versus 71% (for mild) and 12% vs 21% (severe toxicity), respectively). A subset of 107 patients was initially treated with radiotherapy and concurrent and adjuvant temozolomide; within this subset, patients with none or only mild toxicity during 1st line treatment had only a small risk of severe hematological toxicity during 2nd line treatment (4%). In contrast, the 34,5 % of patients with severe hematological toxicity during 1st line treatment also experienced severe hematological toxicity during 2nd line alkylating chemotherapy. CONCLUSION Hematological toxicity occurs more frequently during 2nd line treatment. Treatment with 2nd line temozolomide results in less hematological toxicity than lomustine. Absence of severe toxicity during 1st line treatment is predictive for the risk of toxicity during 2nd line treatment.

Efficacy and safety of PD-1/PD-L1 antibody combined with chemotherapy as second-line or third-line treatment for metastatic small cell lung cancer.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e20574-e20574
Author(s):  
Jun Wang ◽  
Beibei Yin ◽  
Yaping Guan ◽  
Dongfeng Feng
Keyword(s):  
Lung Cancer ◽  
Response Rate ◽  
Objective Response ◽  
Small Cell ◽  
Efficacy And Safety ◽  
Small Cell Lung ◽  
First Line ◽  
Platinum Based Chemotherapy ◽  
Extensive Stage ◽  
Grade 3

e20574 Background: For a small subset of patients, immune checkpoint blockade heralds a promising strategy for achieving disease control in small cell lung cancer (SCLC). Nivolumab or pembrolizumab monotherapy has been granted accelerated approval for treatment of patients with extensive-stage SCLC with disease progression after platinum-based chemotherapy and at least one other line of therapy. Moreover, Based on IMpower133 and CASPIAN data, addition of PD-L1 antibody such as atezolizumab or durvalumab to first-line platinum-based chemotherapy prolongs overall survival over chemotherapy alone. However, it remains exclusive that whether PD-1/PD-L1 antibody combined with chemotherapy is effective against extensive-stage SCLC when progressed on previous chemotherapy. Methods: We reviewed patients with extensive-stage SCLC who have failed in first-line or beyond chemotherapy and received PD-1/PD-L1 antibodies with chemotherapy in a single institute. The efficacy and safety were evaluated. The primary end point was the objective response rate according to Response Evaluation Criteria in Solid Tumors, version 1.1. Results: A total of 11 patients were included in this retrospective cohort study. The median age was 46 years (range from 29 to 62). Seven patients were male. Four were current or former smokers. Six received two prior therapies. Nine had previously received radiation therapy. PD-1 and PD-L1 inhibitors were administrated in 5 and 6 patients, respectively. No patient had a complete response. 2 patients had a partial response, and the objective response rate was 18.2%. 5 patients were evaluated as stable disease with a disease control rate of 63.6%. The median overall survival and progression-free survival was 3.0 months and 2.3 months, respectively. A patient with partial response had a long duration of response of 5.2 months. The most common grade 3 or 4 treatment-related were neutropenia, anemia, and decreased neutrophil count. Most immune-related adverse events were grade 1 or 2, with rash, pruritus and hypothyroidism being the most common, and 1 patient had grade 3 pneumonia. Conclusions: Immunotherapy plus chemotherapy could be beneficial for a subgroup of extensive-stage SCLC patients who have progressed after previous chemotherapy. Further prospective, randomized studies are warranted.

Lenalidomide and Low Dose Dexamethasone As First Line Therapy for Newly Diagnosed Patients with Primary Plasma Cell Leukemia

Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 729-729 ◽  
Author(s):  
Pellegrino Musto ◽  
Vittorio Simeon ◽  
Giovanni D'Arena ◽  
Maria Carmen Martorelli ◽  
Maria Teresa Petrucci ◽  
...  
Keyword(s):  
Plasma Cell ◽  
Low Dose ◽  
Response Rate ◽  
Plasma Cell Leukemia ◽  
Hematological Toxicity ◽  
Cell Leukemia ◽  
First Line ◽  
First Line Therapy ◽  
Primary Plasma Cell Leukemia ◽  
Grade 3

Abstract Abstract 729 Introduction: The prognosis of primary plasma cell leukemia (PPCL) remains poor. The “novel agents” have recently shown promising results in PPCL patients in case reports or small retrospective series. Here we describe the first prospective, multicenter, phase II clinical trial of PPCL, where lenalidomide in combination with low dose dexamethasone (Ld) was tested as initial therapy in newly diagnosed patients fulfilling the IMWG diagnostic criteria of PPCL. Patients and methods: Ld regimen consisted of lenalidomide 25 mg/d for 21 days and oral dexamethasone 40 mg on days 1, 8, 15, and 22 for each 28-day cycle. After 4 cycles, responding patients not eligible for stem cell transplantation (SCT) continued until 8 cycles of full-dose Ld, followed by a maintenance dose of single agent lenalidomide equal to 10 mg/d on days 1–21 of each 28-day cycle. Patients responding after 4 cycles and eligible for SCT proceeded according to the treatment centre's transplant policy. Patients not responding after 4 cycles or progressing during this treatment were considered off-study. Appropriate dose reductions (in particular for patients with reduced renal function at baseline), double contraception methods and anti-thrombotic/anti-infective prophylaxis were recommended. The primary end-point was early response rate according to IMWG uniform response criteria. Secondary end-points were PFS, OS, feasibility and efficacy of SCT, safety. Results: According to the Simon optimal two-stage adaptive design, twenty-three patients were enrolled in between March 2009 and May 2011. The male/female ratio was 1.1, and median age was 60 years (range 44–80). The median absolute number and percentage of circulating plasma cells were 4.280/μl (range 1.500–114.660) and 34% (range 21–90) respectively. Fifteen patients (65.2%) had abnormal renal function at presentation. Twenty-one patients (91.3%) were tested by FISH analysis and cytogenetic abnormalities were detected in all of them, del13q being the most frequently found (16 patients). Seventeen patients showed multiple chromosomal lesions. Involvement of chromosome 14 was observed in 18 patients, three of whom showed t(4;14). Chromosome 1q gain and del17p were detected in 10 and 7 patients, respectively. In the intention-to-treat (ITT) population, overall response rate (ORR) after at least one Ld cycle was 73.9% (17/23), with 8 patients (34.7%) achieving partial remission (PR), 5 (21.7%) very good PR (VGPR), 3 (13%) complete response (CR), and 1(4.3%) near CR (nCR) (VGPR or better: 39%). In the efficacy-evaluable (EE) population, 14 out of 15 patients who received the initially planned 4 Ld cycles (65.2% of the ITT population) responded (ORR 93.3%), achieving 5 PR (33.3%), 5 VGPR (33.3%), 1 near-CR (6.6%) and 3 CR (20%) (VGPR or better: 59.9%). The maintenance phase was reached and safely performed in 4 responding patients not eligible for SCT, 3 of whom relapsed after 2, 8 and 22 months, respectively. After Ld induction therapy, 8 patients received single (n. 4) or double (n. 4) autologous SCT (ASCT); another patient underwent a sequence of ASCT followed by non-myeloablative allogeneic SCT (AlloSCT). Six eligible patients did not receive ASCT frontline, due to initial Ld failure or adverse events; three of them underwent single ASCT (n. 2) or tandem ASCT/non-myeloablative AlloSCT (n. 1) after a bortezomib-based salvage therapy, achieving 2 CR and 1 PR. After a median follow-up of 23 months, median OS and PFS in ITT population were not reached and 22 months, respectively. All transplanted patients remained alive, although three of them relapsed and started salvage treatments; OS was 12 months in the 11 patients who did not receive ASCT (p < 0.001). The correspondent figures for PFS were 29 and 16 months, respectively (p < 0.01). Considering ITT population, multivariate analyses showed that SCT was positively correlated to both OS and PFS. There were 17 episodes of grade 3/4 non hematological toxicity, which occurred in 13 patients (5 infections, 3 renal, 3 metabolic, 2 gastro-intestinal, 2 skin, 1 fatigue, 1 thromboembolic), causing early interruption of Ld treatment in 4 patients. Grade 3/4 hematological toxicity (mainly neutropenia) occurred in 11 patients (47.8%). Conclusions: Ld may be a feasible and effective initial therapeutic option for PPCL, particularly in patients who receive ASCT after a short course of induction treatment. Disclosures: Musto: Celgene: Honoraria, Research Funding. Off Label Use: Lenalidomide as first line therapy of plasma cell leukemia. Petrucci:Celgene: Honoraria. Cascavilla:Celgene: Honoraria. Di Raimondo:Celgene: Honoraria. Caravita:Celgene: Honoraria. Morabito:Celgene: Honoraria. Offidani:Celgene: Honoraria. Bringhen:Celgene: Honoraria. Boccadoro:Celgene: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau. Palumbo:Celgene: Consultancy, Honoraria.

A phase II study of erlotinib monotherpay in patients with previously treated advanced non-small cell lung cancer (NSCLC) without EGFR gene mutation who have never/light smoking history: NEJ006/TCOG0903.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 7561-7561 ◽  
Author(s):  
Yoshiki Ishii ◽  
Makoto Maemondo ◽  
Koichi Okudera ◽  
Kei Takamura ◽  
Yoshiki Demura ◽  
...  
Keyword(s):  
Disease Control ◽  
Gene Mutation ◽  
Response Rate ◽  
Disease Control Rate ◽  
Phase Iii ◽  
Smoking History ◽  
Egfr Gene ◽  
Grade 3 ◽  
Nsclc Patients ◽  
Egfr Gene Mutation

7561 Background: Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) have demonstrated good response in NSCLC harboring EGFR gene mutation. However, survival benefit from erlotinib was observed also in NSCLC patients with wild type (wt) EGFR gene in subsets of several phase III trials. Additionally, smoking status could be a predictive factor of erlotinib efficacy, This study aimed to evaluate the efficacy of erlotinib in Japanese NSCLC patients with wt-EGFR and find a biomarker that predicts the efficacy of erlotinib other than EGFR gene mutation. Methods: The primary endpoint was an objective response rate. Secondary endpoints included disease control rate, overall survival, and safety. Advanced NSCLC patients without EGFR gene mutation who had received one to three prior chemotherapy regimens and who had never smoked or light smoked (Brinkman Index: less than200) were eligible in this study. EGFR gene status was evaluated by the PNA-LNA PCR clamp method. Erlotinib was administered daily (150mg/day) until disease progression or unacceptable toxicities. Results: Forty seven patients were enrolled between March 2010 and November 2011. One patient was excluded for evaluation because having mutation of EGFR. Efficacy and safety were evaluated among 46 patients. Best responses were PR 7 (15.2%), SD 12 (26.1%), PD 26 (46.4%), NE 1 (2.2%). Response rate and disease control rate were 15.2% (95%CI: 4.9-25.5%) and 41.3 % (95%CI 27.1-55.5%) respectively. Grade 3 or 4 adverse events were anorexia (4), skin rash (2), neutropenia (1), leukopenia (1), anemia (2), elevation of AST/ALT (1), rectal ulcer (1), and cerebral infarction (1).Two patients suffered grade 3 interstitial lung disease. Conclusions: This is the first report to evaluate Erlotinib efficacy in selected NSCLC who do not possess EGFR gene mutation. Erlotinib showed significant anti-tumor activity in pretreated never or light smoked Japanese NSCLC patients without EGFR gene mutation. The results of biomakr analysis will be presented at the meeting.

FOLFOX-4 vs. FOLFIRI vs. IROX as first line chemotherapy for metastatic colon cancer: efficacy and toxicity

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 13541-13541
Author(s):  
D. L. Stanculeanu ◽  
R. Matache ◽  
L. Minea ◽  
A. Cringeanu ◽  
R. Anghel
Keyword(s):  
Colorectal Cancer ◽  
Colon Cancer ◽  
Disease Control ◽  
Metastatic Colorectal Cancer ◽  
Response Rate ◽  
Objective Response ◽  
Disease Control Rate ◽  
Disease Rate ◽  
Metastatic Colon Cancer ◽  
First Line

13541 Background: The combination of OXA or IRI with 5FU-LV are accepted as standard treatment for metastatic colorectal cancer. However, the right sequence in first or second line is still under debate. We developed a non-randomised prospective study in first line metastatic colorectal cancer comparing the efficacy and the toxicity of three different chemotherapy regimens - FOLFOX-4 vs. FOLFIRI vs. IROX. Methods: From January 2004 to January 2005 we included in the study 57 patients with metastatic non-resectable colon cancer - 22 in FOLFOX arm, 18 in FOLFIRI arm and 17 in IROX arm. In the FOLFOX arm patients received OXA 85 mg/m2 d1, LV 200 mg/m2 d1,2, 5FU 400 mg/m2 bolus d1,2, 5FU 600 mg/m2 as 22 hours CI d1,2 q15d; in the FOLFIRI arm - IRI 180 mg/m2, LV 400 mg/m2, 5FU 400 mg/m2 bolus and 5FU 2400 mg/m2 as 46 hours CI, q15d; in the IROX arm - IRI 300 mg/m2 d1, OXA 85 mg/m2 d2, q3w. The main patients characteristics were: median age 60 vs 62 vs 59; number of metastatic sites ≥ 2: 41% vs 33.33% vs 35.3%; performance status ECOG 0–1: 86.3% vs 83.3% vs 88.2%. The primary end-point was the objective response rate (CR + PR) and the secondary end-points was the toxicity. The objective response was evaluated every 3 months; at disease progression patients were offered to switch to a comparator regimen. Results: The objective response was 63.6% in FOLFOX arm (with a CR of 9%), 44% in FOLFIRI arm (CR - 5.5%) and 53% in IROX arm (CR - 11,7%); the stable disease rate - 27.3% in FOLFOX arm, 44.4% in FOLFIRI arm, 35.3% in IROX arm and the disease control rate - 91% in FOLFOX arm, 88.8% in FOLFIRI arm and 88.2% in IROX arm. The main grade 3–4 toxicities were: neutropenia - 22.7% vs 16.66% vs 29.4%; febrile neutropenia - 4.5% vs 5.5% vs 11.76%; diarrhea - 9% vs 22.2% vs 23.5%; nausea/vomiting - 4.5% vs 5.5% vs. 11.76%; neuropathy - 18.18% vs 0% vs 17.6%. No patients stoped the treatment because of side effects. Conclusions: All three regimens were well tolerated, with comparable results - with a slightly better disease control rate in the FOLFOX arm and a tendance of a better complete response rate in the IROX arm. The FOLFOX regimen had lower rates of nausea, vomiting, diarrhea; sensitive neuropathy and neutropenia were more common with regimens containing oxaliplatine. The IROX regimen had a higer incidence of adverse effects. No significant financial relationships to disclose.

Gemcitabine combined with capecitabine compared to gemcitabine with or without erlotinib as first-line chemotherapy in patients with advanced pancreatic cancer: Comparative effectiveness study.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e15132-e15132
Author(s):  
Jangho Cho ◽  
Jae Yun Lim ◽  
Jae Yong Cho
Keyword(s):  
Pancreatic Cancer ◽  
Response Rate ◽  
Group Performance ◽  
Advanced Pancreatic Cancer ◽  
Progression Free Survival ◽  
Chemotherapy Response ◽  
First Line ◽  
Combination Drug ◽  
Free Survival ◽  
Line Chemotherapy

e15132 Background: Gemcitabine is the standard treatment for advanced pancreatic cancer. Though capecitabine and erlotinib are accepted as combination agent with gemcitabine, those two combination regimens have not been compared directly in clinical trial. This study compared the efficacy and tolerability between gemcitabine plus capecitabine (GEM-X), gemcitabine plus erlotinib (GEM-T), and gemcitabine monotherapy (GEM) as first-line chemotherapy in patients with advanced pancreatic cancer. Methods: We collected data ofpatients if they met the following criteria: histologically or cytologically confirmed ductal adenocarcinoma of the pancreas; unresectable/metastatic disease; treated with one of GEM, GEM-X, and GEM-T as first-line treatment; measurable or evaluable lesion; age more than 18 years; Eastern Cooperative Oncology Group performance status 0, 1, or 2; and adequate hematologic, hepatic, and renal function before first-line chemotherapy. Response rate, progression-free survival (PFS), overall survival (OS), and toxicity were evaluated. Results: Between January 2007 and November 2011, a total of 127 patients received one of GEM (n=47), GEM-T (n=44), and GEM-X (n=36). GEM-X significantly improved the objective response rate (21.2% vs. 12.7% and 15.9%), progression-free survival (8.9 vs. 5.2 and 3.9 months; p < 0.001) and OS (12.1 vs. 10.4 and 9.9 months; p = 0.03) compared to GEM and GEM-T, respectively. The incidence of adverse events was not significantly different among groups. Conclusions: GEM-X presented better clinical efficacy and acceptable tolerability than GEM-T and GEM in locally advanced and metastatic pancreatic cancers. It is worthy to further investigate which agent has clinical advantage as combination drug with gemcitabine in pancreatic cancer and to explore predictive markers for each regimen leading to personalize anti-cancer treatment.

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