A systematic review and network meta-analysis of second-line therapy in hepatocellular carcinoma

BackgroundIn patients with advanced hepatocellular carcinoma (hcc) following sorafenib failure, it is unclear which treatment is most efficacious, as treatments in the second-line setting have not been directly compared and no standard therapy exists. This systematic review and network meta-analysis (nma) aimed to compare the clinical benefits and toxicities of these treatments.MethodsA systematic review of randomized controlled trials (rcts) was conducted to identify phase iii rcts in advanced hcc following sorafenib failure. Baseline characteristics and outcomes of placebo were examined for heterogeneity. Primary outcomes of interest were extracted for results, including overall survival (os), progression-free survival (pfs), objective response rate (orr), grade 3/4 toxicities, and subgroups. An nma was conducted to compare both drugs through the intermediate placebo. Comparisons were expressed as hazard ratios (hrs) for os and pfs, and as risk difference (rd) for orr and toxicities. Subgroup analyses for os and pfs were also performed.ResultsTwo rcts were identified (1280 patients) and compared through an indirect network; celestial (cabozantinib vs. placebo) and resorce (regorafenib vs. placebo). Baseline characteristics of patients in both trials were similar. Both trials also had similar placebo outcomes. Cabozantinib, compared with regorafenib, showed similar os [hazard ratio (hr): 1.21; 95% confidence interval (ci): 0.90 to 1.62], pfs (hr: 1.02; 95% ci: 0.78 to 1.34) and orr (−3.0%; 95% ci: −7.6% to 1.7%). Both treatments showed similar toxicities, but there were marginally higher risks of grade 3/4 hand–foot syndrome (5%; 95% ci: 0.1% to 9.8%), diarrhea (4.8%; 95% ci: 1.1% to 8.5%), and anorexia (4.4%; 95% ci: 0.8% to 8.0%) for cabozantinib. Subgroup results for os and pfs were consistent with overall results.ConclusionsOverall, this nma determined that cabozantinib and regorafenib have similar clinical benefits and toxicities for second-line hcc.     

Single-agent irinotecan as second-line treatment for advanced gastric cancer

AIM: To investigate the activity and toxicity of irinotecan (CPT-11) as a single agent in patients with advanced gastric cancer after failure of previous 5-fluorouracil-based combination chemotherapy. PATIENTS AND METHODS: Sixteen patients with advanced gastric received CPT-11, 350 mg/m2 every 21 days. The median age of the patients was 54.6 years; ECOG performance status was 0-1 in 14 patients and 2 in 2 patients. Dominant metastatic sites included liver, lung, lymph nodes and peritoneum. RESULTS: No complete response was observed. Two patients (12.5%) achieved a partial response to treatment. One patient (6.25%) had a minor response. Ten patients (62.5%) had progressive disease on therapy, and 3 patients (18.75%) had stable disease. The median survival of all 16 patients was 5 months. Grade 3 neutropenia was observed in 3 patients (18.75%), grade 4 thrombocytopenia in 1 patient (6.25%), and grade 3 anemia in 1 patient (6.25%). Three patients (18.75%) suffered from grade 3 diarrhea. CONCLUSIONS: CPT-11 is moderately active and a well-tolerated regimen for selected advanced gastric cancer patients who experience disease progression after receiving first-line treatment.     

晚期胰腺癌二线治疗的研究进展

一线使用吉西他滨已成为晚期胰腺癌治疗的标准方案，但是目前尚无标准的二线化疗方案。支持二线治疗优于最佳支持治疗的数据少之又少。我们总结已公布的二线化疗方案，大部分为Ⅱ期临床试验，以摘要的形式发表居多，没有单药的广泛研究。以药物的副作用作为代价，二线化疗的益处是非常有限的，但Ⅲ期随机试验还需要继续进行。未来的二线化疗将不仅以有效率或生存期作为评价，还将把临床受益率作为治疗目标。     

Second-line treatments for advanced gastric cancer: Interpreting outcomes by network meta-analysis

AIM: To study the effectiveness of second-line treatments for advancer gastric cancer by application of Bayesian network meta-analysis.METHODS: Our search covered the literature up to February 2015. The following 6 treatments were evaluated: (1) irinotecan (camptothecins); (2) paclitaxel (taxanes class); (3) docetaxel (taxanes); (4) everolimus (mammalian target of rapamycin inhibitors); (5) ramucirumab (vascular endothelial growth factor receptor 2 inhibitors); (6) ramucirumab + paclitaxel. Our methodology was based on standard models of Bayesian network meta-analysis. The reference treatment was best supportive care (BSC). The end-point was overall survival. Median survival was the outcome measure along with 95% credible intervals.RESULTS: Our search identified a total of 7 randomized controlled trials. These trials included 2298 patients (in 15 treatment arms) in whom a total of 6 active treatments were evaluated as well as BSC. There were 21 head-to-head comparisons (6 direct, 15 indirect). The difference in survival between each of two active treatments (paclitaxel and ramucirumab + paclitaxel) vs BSC was statistically significant, while the other 4 showed no statistical difference. In the 6 head-to-head comparisons between active treatments, no significant survival difference was demonstrated.CONCLUSION: Our results indicate that both paclitaxel monotherapy and ramucirumab + paclitaxel determine a significant prolongation in survival as compared with BSC.     

关于进展期胃癌根治术淋巴结清扫范围的荟萃分析

目的 系统评价进展期胃癌根治术中三种不同范围淋巴结清扫术的临床疗效及其安全性.方法 自Medlline、EMBASE、OVID、Cochrane Controlled Tzials Register databaaes和中国生物文献数据库(CBM)等数据库检索有关胃癌根治术不同淋巴结清扫范围的随机对照临床研究(RCTs)文献.评估文献质量并提取数据资料,应用菩萃分析专用软件包RevMan 4.2进行菩萃分析.结果 经质量评估后有关于10个RCT的15篇文献符合本研究要求被纳入分析.单纯Meta分析结果显示,D2根治术与D1根治术相比5年生存率没有明显差异;而在并发症发生率和术后死亡率方面,D2根治术高于D1根治术;仔细分析各RCT的质量和考虑可能存在的偏倚后,结果显示有经验的外科医生宴施D2根治术是安全的.并且可以改善进展期胃癌患者的预后.同时Meta分析显示,尽管D2根治术加腹主动脉旁淋巴结清扫术(D2+PAND)与D2根治术相比并发症发生率和术后死亡率无差异,但D2+PAND术式的5年生存率并没有提高.结论 D2根治术应作为进展期胃癌患者的标准根治术式.     

Chemoradiotherapy regimens for locoregionally advanced nasopharyngeal carcinoma: A Bayesian network meta-analysis

BackgroundConcurrent chemoradiotherapy followed by adjuvant chemotherapy (CRT-A) is often the regimen of choice in locoregionally advanced nasopharyngeal carcinoma (NPC). Many alternative regimens have been reported in the literature, however, it is unknown how effective these regimens are compared to each other due to the lack of direct comparisons. Our objective was to perform a network meta-analysis (NMA) to determine the relative survival benefits of these treatments for locoregionally advanced NPC.MethodsWe performed a systematic review following the Cochrane methodology, using MEDLINE, EMBASE and CENTRAL to identify all randomised controlled trials (RCTs) that compared different chemoradiotherapy regimens for locoregionally advanced NPC. Overall survival (OS) was the primary outcome of interest, and hazard ratios (HRs) were extracted using the Parmar method. Bayesian NMAs with random effects were conducted using WinBUGS.ResultsTwenty-five RCTs (5576 patients) were included in this review. All together, these trials compared seven different regimens: radiotherapy (RT), concurrent chemoradiotherapy (CRT), neoadjuvant followed by CRT (N-CRT), CRT-A, RT-A, N-RT and N-RT-A. All regimens that contained CRT performed significantly better than RT. CRT-A did not improve survival compared to CRT alone (0.98; 95% credible regions: 0.71–1.34). For N-CRT versus CRT, the HR was 1.03 (0.69–1.47). When CRT-A was compared against N-CRT, the resulting HR was 0.96 (0.64–1.48).ConclusionsAdjuvant chemotherapy does not appear to improve survival following CRT. The efficacies of CRT, CRT-A and N-CRT all appeared to be similar. Further studies are warranted to determine the value of additional chemotherapy phases in specific patient subgroups.     

S-1-based therapy versus 5-FU-based therapy in advanced gastric cancer: a meta-analysis

We set out to evaluate the efficacy and safety of S-1-based therapy versus fluorouracil (5-FU)-based therapy in advanced gastric cancer (AGC). Eligible studies were identified from Pubmed, EMBASE, and Cochrane Library. Additionally, abstracts presented at American Society of Clinical Oncology (ASCO) conferences held between January 2000 and November 2009 were searched to identify relevant clinical trials. The outcome included overall survival (OS), overall response rate (ORR), and grade 3/4 advent events. Four randomized controlled trials (one full text and three abstracts) with 2,115 participants in AGC were identified in our analysis(1,065 patients were in the S-1-based group, 1,050 patients were in the 5-FU-based group). Meta-analysis showed there was significant OS benefit in favor of S-1-based therapy (hazard ratio [HR] = 0.87, 95% confidence interval [CI]: 0.79 to 0.96). Pooled estimate for ORR showed no significant difference between S-1-based group and 5-FU-based group (OR = 1.25, 95%CI: 0.31 to 5.09). Lower incidence of grade 3/4 neutropenia was observed in patients with S-1-based therapy (OR = 0.33, 95%CI: 0.25 to 0.44). With regard to grade 3/4 anemia (OR = 1.20, 95%CI: 0.74 to 1.96), leucopenia (OR = 1.09, 95%CI: 0.43 to 2.74), stomatitis (OR = 2.65, 95%CI: 0.12 to 58.89), diarrhea (OR = 0.53, 95% CI: 0.00 to 229.10), nausea (OR = 1.36, 95%CI: 0.68 to 2.72), and treatment-related deaths (OR = 1.84, 95%CI: 0.95 to 3.54), equivalent frequencies were found between groups. S-1-based therapy significantly improved OS in relation to 5-FU-based therapy. ORR and safety profile were considerable between two groups. These results needed to be confirmed by high-quality trials and further studies in the West.     

Docetaxel plus cisplatin as second-line therapy in metastatic or recurrent advanced gastric cancer progressing on 5-fluorouracil-based regimen

The purpose of this study was to determine the activity and safety of docetaxel plus cisplatin as second-line chemotherapy for advanced gastric cancer. This trial included patients who had failed first-line chemotherapy with a 5-fluorouracil regimen within 1 year before their enrollment. After registration, patients were treated with docetaxel intravenously at a dose of 60 mg/m2 given over 1 hour followed by cisplatin 60 mg/m2 given over 2 hours. The treatment was continued every 3 weeks until disease progression or unacceptable toxicity was detected. Forty-three patients were registered and 41 were assessable for response. Seven partial responses were observed (17.1% of the "evaluable" patients; 95% confidence interval [CI], 0-29) with a median response duration of 3.9 months. Stable disease was documented in 2 cases (4.9%). The median survival was 5.8 months (95% CI, 3.4-8.3), resulting in a 1-year survival rate of 23%. Tolerance was acceptable, with the main toxicity being neutropenia. The authors conclude that second-line chemotherapy with docetaxel plus cisplatin for advanced gastric cancer is feasible with an acceptable toxicity level.     

Weekly paclitaxel as second-line chemotherapy for advanced or recurrent gastric cancer

Background Paclitaxel scheduled every 3 weeks has shown a response rate of ∼20% for gastric cancer, with modest hematological toxicity. Weekly administration of paclitaxel in patients with breast or ovarian cancer has shown equivalent efficacy and milder toxicity compared with an every-3 week schedule. We investigated, retrospectively, the antitumor effects and toxicity profiles of weekly paclitaxel for patients with metastatic or recurrent gastric cancer in clinical practice. Methods In 38 patients who had metastatic or recurrent histologically confirmed gastric cancer and a history of one prior chemotherapy regimen, other than paclitaxel or docetaxel, paclitaxel (8mg/m²) was administered weekly, three times every 4 weeks, with short-term premedication. Results All 38 patients had had prior chemotherapy that included 5-fluorouracil, the fluoropyrimidine anticancer drug S-1, or cisplatin. The median number of courses in the present regimen was 6 (range, 1–44+). Dose intensity was 5mg/m² per week, corresponding to 92% of the planned dose (6mg/m² per week). The overall response rate was 24% (6/25) in measurable lesions, and pleural effusion and ascites disappeared in 2 of 7 patients (29%) and in 3 of 21 patients (14%), respectively. Median survival time was 151 days from the commencement of this treatment, with a median follow-up period of 260 days. Grade 3 or 4 leukopenia and neutropenia were observed in 11 (29%) and 12 (32%) patients, respectively. Seven patients (18%) died within 30 days of the last administration of paclitaxel. Conclusion Weekly paclitaxel seems to be active as second-line chemotherapy against metastatic and recurrent gastric cancer. Further study is needed to confirm the efficacy and safety of weekly paclitaxel.     

Esophageal cancer: a critical evaluation of systemic second-line therapy

The objective of this article was to review clinical trials that used antineoplastic second-line chemotherapy and/or targeted therapies in patients with esophageal cancer after first-line therapy. Computerized (MEDLINE) and manual searches were performed to identify articles published on this topic between 1996 and 2011. Twenty-five published trials and four abstracts presented at scientific meetings were identified. A total of 10 trials included only patients with squamous cell carcinomas (SCCs), four focused exclusively on adenocarcinoma (AC), the remaining 15 studies included both SCC and AC. The majority of trials (17 of 29) used docetaxel in combination with platinum analogs, eight used single-agent cytotoxic chemotherapy, and six evaluated targeted therapies. The numbers of patients were relatively small, ranging from eight to 55 patients. The response rates were generally low (between 0% and 39%), with only two small studies reporting objective responses of 50% and 63%, respectively. Time to progression ranged from 1.4 to 6.2 months, and the overall survival was disappointing at 4.0 to 11.4 months. Approximately 40% of patients who experience progressive disease after first-line chemotherapy are able to undergo second-line treatment. On the basis of data published so far, no standard second-line therapy has emerged. Future research will need to focus on individual therapy strategies such as genetic receptor mutations to increase the therapeutic outcome.     

SOX方案二线治疗晚期胃癌的疗效观察

目的:观察SOX方案（奥沙利铂联合替吉奥）二线治疗晚期胃癌的临床疗效和安全性。方法:经含蒽环类药物的ECF方案(表阿霉素联合顺铂、氟尿嘧啶)治疗失败后的晚期胃癌患者40例,应用奥沙利铂（OXA）联合替吉奥(S-1)方案:OXA 130mg/m2,第1天静脉滴注;S-1根据体表面积(BSA)按80、100或120mg/d给药,第1-14天每天分2次口服;持续至疾病进展或出现不可耐受的不良反应。每2个周期按照RECIST标准(1.1版)进行疗效评价及分析患者生活质量改善情况,按NCI-CTC(4.0版)评价不良反应并随访疾病进展时间。结果:40例可评价的患者中获得完全缓解2例,部分缓解11例,疾病稳定13例,疾病进展14例,有效率32.5%,总的疾病控制率为65%,大部分患者生活质量得到明显改善,中位疾病进展时间为3.7个月,主要不良反应为血象降低、轻度末梢神经病变、肝功能异常和消化道反应。结论:奥沙利铂联合替吉奥化疗方案二线治疗晚期胃癌效果明显,应用方便且不良反应少,患者耐受性良好,值得临床深入观察。     

Docetaxel and irinotecan as second-line therapy for advanced oesophagogastric cancer

Introduction

Systemic chemotherapy improves survival in oesophagogastric cancer however no standard second-line regimen exists due to a paucity of randomised data. Docetaxel combined with irinotecan (DI) provides a suitable option due to the lack of cross-reactivity with first-line therapeutics and a tolerable toxicity profile.

Methods

We retrospectively reviewed a cohort of patients with advanced oesophagogastric cancer in two institutions treated with the combination of docetaxel 35 mg/m² plus irinotecan 60 mg/m² day 1 and day 8 every 21 days, following progression with first-line platinum-based therapy.

Results

Between January 2000 and September 2009, 41 eligible patients were identified. Median age was 58 years, male:female 25:16, adenocarcinoma:squamous cell carcinoma 37:4, oesophageal:oesophagogastric junction:gastric 7:10:24. Locally advanced:metastatic disease 6:35. Previous radical surgery:radiotherapy:both 6:4:7. 27/41 had progressed within 90 days of receiving platinum-based therapy. Median number of chemotherapy cycles: 3 (range 1-12). Eight patients required dose reductions due to DI toxicity. 10/28 evaluable patients had a response, median progression-free survival (PFS) was 11 weeks (95% confidence intervals (CI): 9-13 weeks) with median overall survival 24 weeks (95%CI: 12-35 weeks). No significant prognostic factors were identified.

Conclusion

Weekly docetaxel combined with irinotecan has acceptable safety and modest efficacy in the second-line treatment of advanced oesophagogastric cancer. Further prospective evaluation of this regimen is warranted.     

Radiation therapy for advanced gastric cancer

A retrospective study of 75 patients with advanced inoperable gastric cancers, referred to the National Cancer Center Hospital between 1962 and 1982, was performed. According to the Borrmann classification based on X ray findings, Type 1 was found in 3 patients, Type 2 in 5, Type 3 in 40, and Type 4 in 15. Twelve patients could not be classified. The histological type was papillary adenocarcinoma in 7 patients, tubular adenocarcinoma in 23, mucinous carcinoma in 6, poorly differentiated adenocarcinoma in 14, signet ring cell carcinoma in 12 and others in 13. The site of remote metastasis in 19 patients was Virchow's lymph node in 8 patients, Douglas pouch in 3, liver and lung in 2 each and others in 4. All patients were treated by a either telecobalt 60 unit or a linear accelerator using 6 Mv photon and the total dose to primary lesion was 4000 cGy in 5 weeks to 7000 cGy in 8-9 weeks. Complete response (CR) was achieved in 6 patients or 8.0%, partial response (PR) in 46 or 61.3%, and no change (NC) in 23 or 30.7%. The response rate based on the sum of CR and PR was about 70%. The 50% survival period in months was 26.5, 7.3, and 3.2, respectively for patients with CR, PR, and NC. For the response of advanced gastric cancer to chemotherapy in the National Cancer Center Hospital, the combined use of UFT and Mitomycin C gave the highest rate, 46%. As for as local response is concerned, the response rate to radiation was 70%, a better result than that of chemotherapy alone.     

Novel therapy for advanced gastric cancer

Gastric cancer (GC) is a common lethal malignancy. Gastroesophageal junction and gastric cardia tumors are the fastest rising malignancies due to increasing prevalence of obesity and acid reflex in the United States. Traditional chemotherapy remains the main treatment with trastuzumab targeting human epidermal growth factor receptor 2 positive disease. The median overall survival (OS) is less than one year for advanced GC patients; thus, there is an urgent unmet need to develop novel therapy for GC. Although multiple targeted agents were studied, only the vascular endothelial growth factor receptor inhibitor ramucirumab was approved recently by the United States Food and Drug Administration because of its 1.4 mo OS benefit (5.2 mo vs 3.8 mo, P = 0.047) as a single agent; 2.2 mo improvement of survival (9.6 mo vs 7.4 mo, P = 0.017) when combined with paclitaxel in previously treated advanced GC patients. It is the first single agent approved for previously treated GC and the second biologic agent after trastuzumab. Even with limited success, targeted therapy may be improved by developing new biomarkers. Immune therapy is changing the paradigm of cancer treatment and is presently under active investigation for GC in clinical trials. More evidence supports GC stem cells existence and early stage studies are looking for its potential therapeutic possibilities.     

S-1-based therapy versus S-1 monotherapy in advanced gastric cancer: a meta-analysis

This study aimed to derive a more precise estimate of the prognostic significance of S-1-based therapy over S-1 monotherapy in patients with advanced gastric cancer (AGC), including overall survival (OS) time, progression-free survival (PFS) time, objective response rate (ORR), and adverse events (AEs). Studies stratifying OS, PFS, ORR, and AEs in AGC patients in an S-1-based therapy versus an S-1 monotherapy setting were eligible for analysis by systematic computerized PubMed, Embase and Cochrane Library searches. Data from these studies were pooled using STATA package version 11.0. Six studies that investigated outcomes in a total of 913 AGC cases, of which 443 (48.5 %) received S-1-based therapy and 470 (51.5 %) received S-1 monotherapy, were included in the meta-analysis. Median OS and median PFS were significantly prolonged in AGC patients receiving S-1-based therapy compared with those receiving S-1 monotherapy (hazard ratio [HR] 0.83, 95 % confidence interval [CI] 0.71–0.96, P?=?0.015, and HR 0.69, 95 % CI 0.60–0.80, P?=?0.000, respectively). The ORR favored patients with S-1-based therapy (OR 1.65, 95 % CI 1.34–2.06, P?=?0.000). Higher incidence of grade 3/4 neutropenia was found in patients with S-1-based therapy (P?=?0.000). For the Asian population, S-1-based therapy significantly improved OS and PFS and enhanced ORR in comparison to S-1 monotherapy. The safety profile was poorer in patients with S-1-based therapy, but could be considerable between the S-1-based therapy and S-1 monotherapy group. Our conclusion needs to be confirmed via high-quality trials and the results need to be reproduced in other regions and populations.     

Efficacy and cost-effectiveness of second-line chemotherapy in elderly patients with advanced gastric cancer

Purpose

Second-line chemotherapy has been shown to benefit patients with advanced gastric cancer (AGC), extending the overall survival (OS) and progression-free survival (PFS). This study aimed to assess the efficacy and cost-effectiveness of second-line treatment for elderly patients with AGC.

Methods

Medical records and follow-up information of elderly patients (≥70 years) with AGC who received second-line chemotherapy were collected. A Markov model comprising three health states PFS, progressive disease and death was developed to simulate the process of AGC. Cost was calculated from the perspective of Chinese society. Sensitivity analyses were applied to explore the impact of essential variables.

Results

Forty-three elderly patients with AGC receiving second-line chemotherapy were included in our study. The median OS was 6.0 months (95% confidence interval (CI) 3.90–8.10) and PFS was 3.1 months (95% CI 1.38–4.82). No treatment-related death occurred. The most frequently drug-related grade 3/4 AEs were diarrhea (2.3%), leukopenia (16.3%) and nausea (7.0%). The incremental cost-effective ratio was $18,223.75/QALY for second-line chemotherapy versus BSC, which was below the threshold of 3× the per capita GDP of China, $23,970.00.

Conclusion

Second-line chemotherapy was an optimal strategy for elderly AGC patients in China from the efficacy and cost-effectiveness perspective.

     

Quality of life in patients with advanced gastric cancer treated with second-line chemotherapy

Objective: Despite many trials of systemic chemotherapy in advanced gastric cancer, treatment after failure with first-line chemotherapy remains controversial. We prospectively assessed quality of life (QL) in gastric cancer patients treated with second-line chemotherapy. Methods: Forty-three patients who received second-line chemotherapy for advanced gastric cancer completed the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 and hospital anxiety and depression scale (HADS) at baseline and at regular intervals during and after chemotherapy. Results: Compliance with QL questionnaire completion decreased to 72% after third cycle of treatment. In general, clinically meaningful improvements compared with baseline (change QLQ-C30 scores ≥10) were seen in a number of domains and items, including global health/QL, emotional function, cognitive function and all of the symptom scales and single items but appetite. There was no difference in QL between responders and non-responders (P=0.473). At baseline, 27 (63%) patients were suspected to have anxiety or depressive disorder (HADS score ≥11), and this incidence decreased after chemotherapy (14.7 vs 9.5; P<0.001). Conclusion: Improvements from baseline in QL measures and HADS scores were demonstrated in patients with advanced gastric cancer, treated with second-line chemotherapy.     

Docetaxel and oxaliplatin combination in second-line treatment of patients with advanced gastric cancer

Background In advanced gastric cancer few data are available on the efficacy or safety of new drug combination regimens after progression following first-line chemotherapy. Methods Patients with histologically confirmed advanced gastric cancer and Eastern Cooperative Oncology Group (ECOG) performance status (PS) less than 2, progressing after first-line chemotherapy, were eligible. Patients were treated with docetaxel 75 mg/m² on day 1 and oxaliplatin 80 mg/m² on day 2, every 3 weeks, until progression or unacceptable toxicity. Results Between May 2002 and April 2005, 38 patients were enrolled. Men accounted for 73.7% of the patients and the median age was 59 years. The primary tumor was not resected in 47.4% of the patients; the peritoneum was the most frequent metastatic site (60.5%). The first-line treatment was cisplatin, epirubicin, and infusional 5-fluorouracil (ECF) in 81.5% of the patients and cisplatin and infusional 5-fluorouracil (CF) in 15.7%. The median number of cycles was 4.3. The treatment was well tolerated, with no toxic deaths. National Cancer Institute (NCI) grade III-IV neutropenia was frequent (26.3%), but no febrile neutropenia was reported. Severe asthenia (15.7%) and severe nausea (15.7%) required dose reductions in 2 patients and treatment discontinuation in another. The overall response rate was 10.5%, and 18 patients (47.3%) experienced disease stabilization (7 of them with significant clinical benefit). Median time to progression was 4.0 months (range, 2–8 months) and median overall survival was 8.1 months (range, 3–26 months). Thirteen patients (34.2%) also received third-line chemotherapy, with an irinotecan-containing regimen, and their median overall survival was higher than that of the other patients (16.3 vs 6.0 months) Conclusion The combination of oxaliplatin and docetaxel shows only marginal activity as second-line treatment, but it has a good tolerability profile. This suggests that there is room for optimizing the schedule as well as for planning sequential treatments in gastric cancer.