Paclitaxel, 5-fluorouracil, and cisplatin combination chemotherapy for the treatment of advanced gastric carcinoma

BACKGROUND: Although the clinical efficacy of paclitaxel in the treatment of gastric carcinoma has not been clearly defined, recent reports have suggested a possible role in the treatment of upper gastrointestinal carcinomas in vitro and in vivo. In this study, the authors evaluated the efficacy and toxicity of a combination chemotherapy that included paclitaxel, 5-fluorouracil (5-FU), and cisplatin in the treatment of patients with advanced gastric carcinoma. METHODS: Forty-one gastric carcinoma patients with metastatic disease, unresectable advanced disease, or relapsed disease were treated with the following regimen, administered every 28 days: paclitaxel 175 mg/m2 by 3-hour intravenous (i.v.) infusion on Day 1, 5-FU 750 mg/m2 by 24-hour continuous i.v. infusion on Days 1-5, and cisplatin 20 mg/m2 by 2-hour i.v. infusion on Days 1-5. Twenty-six patients had measurable disease, and 15 had evaluable disease. All patients were assessable for toxicity. RESULTS: Twenty-one of the 41 patients (51%; 95% confidence interval [CI], 36.5-65.7%) demonstrated an objective response, including 4 complete responses (10%; 95% CI, 3.9-22.5%). Sixty-five percent of the patients with measurable disease (17 of 26; 95% CI, 58-92.5%) and 27% of the patients with evaluable disease (4 of 15: 95% CI, 11.1-52.3%) achieved a complete response or a partial response. The median response duration was 17 weeks (range, 4-90 weeks), and the median survival duration for all patients was 26 weeks (range, 8 to 118+ weeks). The major toxicity of this treatment was myelosuppression with neutropenia of World Health Organization Grade 3 and 4 in 24% and 10% of the patients, respectively. Nonhematologic toxicity included mucositis, nausea/vomiting, diarrhea, neurotoxicity, and alopecia. Fluid retention occurred in two patients, and one patient had an anaphylatic reaction. Dose reduction was necessary for one patient, because Grade 4 neutropenia and mucositis occurred. CONCLUSIONS: Paclitaxel, 5-FU, and cisplatin was an active combination regimen in the treatment of advanced gastric carcinoma. The toxicity of this regimen was tolerable. Based on these findings, this combination regimen could be an attractive treatment in the preoperative setting.     

小剂量FP方案治疗晚期消化道肿瘤的临床观察

目的　观察低剂量氟脲嘧啶 (5 -FU)持续输注联合低剂量顺铂 (DDP)方案治疗晚期消化道恶性肿瘤的疗效。方法　 5 -FU2 0 0mg/m2 /d ,持续静脉输注 3～ 4周。DDP6mg/m2 /d ,静脉输注 1小时 ,每周用 5d ,连用 3～ 4周。以上方案连用二周期为一疗程 ,化疗后休息 1个月评定疗效。结果　全组 34例 ,总有效率为6 4 71% ,其中PR2 2例。胃癌、食管癌、结肠癌、胰腺癌的有效率分别为 :6 2 5 0 %、10 0 0 0 %、33 33%、5 0 0 0 % ;中位缓解期 4 8个月 (2～ 9个月 )。没有Ⅲ°～Ⅳ°毒副反应。结论　低剂量 5 -FU持续输注联合低剂量DDP方案治疗晚期消化道恶性肿瘤是一个有效低毒的化疗方案     

Biweekly docetaxel, cisplatin, and 5-fluorouracil (DCF) chemotherapy for advanced esophageal squamous cell carcinoma: a phase I dose-escalation study

Background and purpose

The optimal chemotherapeutic protocol for the treatment of esophageal cancer has not yet been established. A dose-escalation study of docetaxel combined with cisplatin and 5-fluorouracil (5-FU) was performed to determine the optimal dose in patients with advanced esophageal squamous cell carcinoma.

Patients and method

We studied a total of 18 patients who had previously untreated thoracic esophageal squamous cell carcinoma with T4 tumors and/or metastasis. The patients received an infusion of docetaxel at different dose levels (levels 1, 2, 3: 30, 35, 40 mg/m², respectively) and an infusion of cisplatin (40 mg/m²) on days 1 and 15 plus a continuous infusion of 5-FU (400 mg/m²/day) on days 1–5 and 15–19.

Results

Dose-limiting toxicities (DLT) included febrile neutropenia and leukopenia. DLT occurred in 2 of 6 patients at level 1, 2 and in 3 of 6 patients at level 3. The response rate was 88.9%, including a complete response rate of 33.3%.

Conclusions

To minimize toxicity and maximize dose intensity, we elected to investigate a biweekly regimen. The maximum tolerated dose was level 3, and the recommended dose was determined to be docetaxel 35 mg/m² with cisplatin 40 mg/m² plus 5-FU 400 mg/m², administered biweekly. This regimen was tolerable and highly active. A phase II study has been started.     

Sequential combination chemotherapy with methotrexate and 5-fluorouracil in advanced colorectal carcinoma

Twenty patients bearing advanced colorectal carcinoma, confirmed by histology, were evaluated after undergoing a sequential chemotherapeutic schedule which consisted of methotrexate, 200 mg/m2 in intravenous infusion during 4 h followed 1 h later by 5-fluorouracil, 600 mg/m2 in intravenous bolus. Twenty hours after ending the MTX administration, leucovorine, 14 mg/m2, was given intramuscularly every 6 h, in 8 doses. Courses were repeated every 15 days. Of 20 patients, 3 bearing colon carcinoma, without previous radiotherapy or chemotherapy, had a partial response. No change was registered in 6 cases. There was no significant difference in the survival of responders, those with stable illness and those with progression. Results were no better than those obtained with 5-fluorouracil used as a single drug and are in agreement with studies that established a 1-h interval between the administration of both drugs.     

Experience with combination of docetaxel, cisplatin plus 5-fluorouracil chemotherapy, and intensity-modulated radiotherapy for locoregionally advanced nasopharyngeal carcinoma

Background

Our aim was to evaluate the efficacy and toxicity of cisplatin, fluorouracil, and docetaxel chemotherapy plus intensity-modulated radiotherapy (IMRT) for locoregionally advanced nasopharyngeal carcinoma (NPC).

Methods

Sixty patients with locoregionally advanced NPC were enrolled. Patients received IMRT plus three courses of neoadjuvant chemotherapy and two courses of adjuvant chemotherapy consisting of docetaxel (60 mg/m²/day on day 1), cisplatin (25 mg/m²/day on days 1–3), and 5-fluorouracil (500 mg/m²/day on days 1–3).

Results

The overall response rate to neoadjuvant chemotherapy was 89 %. Three months after the completion of radiotherapy, 53 (93 %) patients achieved complete regression, 3 (5 %) achieved partial response (PR), and 1 experienced liver metastasis. However, among the 3 PR patients, 2 patients had no evidence of relapse in the follow-up. With a median follow-up of 27 months (range, 6–43), the 2-year estimated locoregional failure-free survival, distant failure-free survival, progression-free survival, and overall survival were 96.6, 93.3, 89.9, and 98.3 %, respectively. Leukopenia was the main adverse effect in chemotherapy; 14 patients experienced grade 3 or grade 4 neutropenia, and 1 patient developed febrile neutropenia. The nonhematological adverse events included alopecia, nausea, vomiting, anorexia, and diarrhea. The incidence of grade 3 acute radiotherapy-related mucositis was 28.3 %; no grade 4 acute mucositis was observed. No grade 3 or grade 4 hematological toxicity occurred during radiotherapy. None of the patients had interrupted radiotherapy. The common late adverse effects included xerostomia and hearing impairment.

Conclusions

Neoadjuvant–adjuvant chemotherapy using cisplatin, fluorouracil, plus docetaxel combined with IMRT was an effective and well-tolerated alternative for advanced NPC.     

Combination chemotherapy of cisplatin and 5-fluorouracil for advanced colorectal adenocarcinoma

Summary A total of 24 patients with advanced colorectal adenocarcinoma were entered into a phase I–II study of 5-fluorouracil (5-FU) and cisplatin, 21 of whom had previously received 5-FU. The starting dose of cisplatin was 20 mg/m² diluted in 1000 cc normal saline, given over 20 h daily for 5 days, together with 600 mg/m² 5-FU diluted in 1000cc fluid, given simultaneously over 20 h daily for 5 days. This regiment was given every 4 weeks. The dose-limiting toxicity was renal and cumulative. All 24 patients were evaluable for toxicity. Of 12 patients on the abovementioned starting dose, 8 underwent a cisplatin dose reduction to 15 mg/m² due to a progressive decrease in creatinine clearance following the second or third course of treatment. Of 12 patients who started cisplatin at 15 mg/m² and 5-FU at 600 mg/m², 11 were maintained at this dose. A WBC nadir count of<2000/mm³ was seen in four patients. Thrombocytopenia occurred in three patients who received 15 mg/m² cisplatin and 600 mg/m² 5-FU. In all, 21 of the 24 patients had objectively measurable disease and were also evaluable for response as follows: 1 complete response, 2 partial responses, 1 case of stable disease, and 17 patients with progressive disease.     

Problems and prospects for combined chemotherapy with 5-fluorouracil and low-dose cisplatin]

Recently, the efficacy of combined chemotherapy with 5-fluorouracil and low-dose cisplatin for advanced gastrointestinal cancer has been reported in Japan. However, this method has not become established, because the underlying logic is unclear and the quality of its clinical trials has been unsatisfactory. We suggest the mechanism for this depends not only on the action of CDDP as a modulator of 5-FU, but also on a mutual biochemical modulation in which 5-FU acts as a modulator of CDDP and enhances the effect of CDDP. We expect that numerous phase II studies and the accumulation of reliable data will lead to improvements.     

Study of continuous arterial infusion chemotherapy with low-dose cisplatin and 5-fluorouracil for patients with hepatocellular carcinoma

Seven patients with postoperative recurrence of hepatocellular carcinoma (HCC) and four patients who underwent absolute non curative resection for HCC were treated with continuous arterial infusion of low-dose cisplatin (CDDP) (10 mg/body/day) and 5-fluorouracil (5-FU) (250 mg/body/day). This infusion chemotherapy was continued for five days and discontinued for two days, repeated over four weeks as one course. The response rate in patients with postoperative recurrence was 42.9%, while that in patients who underwent reduction surgery for multiple HCC was 75%. Continuous arterial infusion of low-dose CDDP/5-FU may be effective in patients with multiple small intrahepatic metastases.     

联合化疗方案治疗晚期胃癌的临床疗效分析和安全性评估

目的探讨联合化疗方案PDF即紫杉醇（PTX）＋顺铂（DDP）＋5-氟尿嘧啶（5-Fu）治疗晚期胃癌的临床疗效情况和安全性。方法入选2008年1月至2010年12月期间晚期胃癌患者80例,随机分为治疗组（40例）和对照组（40例）。对照组患者采用5-Fu治疗。治疗组患者采用PTX（135mg／m^2）静脉滴注3h,第1天;DDP（25mg／m^2）静脉滴注,第1—3天;5-Fu（750mg／m^2）静脉滴注,第1～5天,28天为1个化疗周期。2个周期后分析两组患者的疗效和不良反应。结果治疗组患者中,完全缓解（CR）8例,部分缓解（PR）10例,稳定（SD）15例,进展（PD）7例,临床有效率为45．0％,临床受益率为82．5％,明显高于对照组。治疗组患者的不良反应主要是骨髓抑制和消化道反应,症状较轻,不良反应明显低于对照组。结论采用联合化疗方案治疗晚期胃癌可提高疗效,且不良反应较轻,值得临床上推广。     

Weekly cisplatin/low-dose gemcitabine combination for advanced and recurrent cervical carcinoma

The aim of this study was to evaluate the activity and safety of the weekly cisplatin/low-dose gemcitabine combination in advanced or recurrent cervix cancer. Fourteen patients were treated with weekly chemotherapy consisting of gemcitabine 100 mg/m2 and cisplatin 33 mg/m2 for a maximum of 18 courses (6 months). The response rate and survival was evaluated. The mean age of patients was 43.4 years, 13 out of 14 had pelvic disease, and most of them received previous irradiation. Eleven patients were evaluated for response and all for toxicity. The mean number of courses delivered was 9.7. Four patients (36%) achieved a partial response and four had stable disease. The most frequent toxicity was nausea/vomiting;myelosuppression was mild and uncommon. At a maximum follow-up of 15 months the median survival was 6 months. This is an active and well-tolerated combination devoid of myelotoxic effects which allows its administration without delays.     

Second-line chemotherapy with combined irinotecan and low-dose cisplatin for patients with metastatic gastric carcinoma resistant to 5-fluorouracil

Although 5-fluorouracil (5-FU) is still the mainstay of systemic treatment for patients with metastatic gastric cancer, many patients do not show satisfactory response to this drug. We treated patients with metastatic gastric cancer resistant to 5-FU with a combination of irinotecan hydrochloride (I) and low-dose cisplatin (P). Twenty-one consecutive patients with advanced metastatic gastric cancer and performance status of 0-2, who had received prior chemotherapy with S-1, but had nonetheless shown unrelenting tumor progression, were treated with 60 mg/m(2) of I combined with 6 mg/m(2) of P, administered by intravenous infusion over 90 min following premedication with azasetron (I/low-P). I/low-P was repeated weekly for 3 weeks with the patient admitted to hospital, and thereafter, fortnightly on an outpatient basis. Seven, eight and six of the total of 21 patients had liver metastases, lymph node metastases and peritoneal dissemination, respectively. Objective response was observed in 11 of the 21 patients (52%; 95% confidence interval: 31-78%). Two (18%) and nine (82%) of these 11 patients exhibited complete and partial response, respectively. The median duration of the response was 7.9 months. The treatment regimen under study was tolerated very well by the patients. Thirteen of the 21 patients (62%) developed grade 1 or 2 leucopenia, which was the most common adverse reaction recorded. Diarrhea and nausea, grade I in all of the cases, occurred in five (22%) and nine (43%) patients, respectively. Based on its remarkable effectiveness, marked improvement in the quality of life of the patients, and the convenience of its administration, the I/low-P regimen is recommended as a promising second-line chemotherapeutic regimen for patients with metastatic gastric cancer resistant to 5-FU.     

替吉奥联合顺铂与5-氟尿嘧啶联合顺铂治疗晚期胃癌对照研究的Meta分析

目的:比较替吉奥联合顺铂方案(SP方案)和5-氟尿嘧啶联合顺铂方案(FP方案)一线治疗晚期胃癌的疗效及安全性。方法:计算机检索Pubmed、EMBASE、Cochrane Library、ASCO会议摘要、中国期刊全文数据库、中国生物医学文献数据库、中文科技期刊全文数据库等,同时追查纳入文献的参考文献,纳入SP方案对比FP方案治疗晚期胃癌的随机对照试验(RCT)。根据Cochrane Handbook 5.0的质量评价标准,用RevMan 5.0软件进行统计学分析。结果:纳入4项RCT,1 263例患者,Meta分析结果显示,采用SP方案与FP方案治疗后疗效相当(OR=1.58,95%CI:0.76～3.29,P=0.22),但可以降低3/4级血小板减少(OR=0.58,95%CI:0.40～0.85,P=0.004)及恶心呕吐(OR=0.70,95%CI:0.52～0.95,P=0.02)发生率;亚组分析(中国人群),纳入3项RCT,234例患者,Meta分析结果显示,与FP方案相比,SP方案可提高患者有效率(OR=2.39,95%CI:1.30～4.38,P=0.005),但不能降低不良反应发生率,差异均无统计学意义。结论:SP方案与FP方案在有效率方面疗效相当,但可以增加安全性,不良反应发生率与FP方案类似,但由于研究例数较少,该结论尚待进一步扩大样本量进行评估。     

A case of advanced esophageal carcinoma successfully treated with chemoradiation therapy with low-dose cisplatin and 5-fluorouracil

We have experienced a case of advanced esophageal carcinoma successfully treated with chemoradiation therapy together with low-dose cisplatin and 5-fluorouracil, having only minor toxicity. A 55-year-old man was admitted to our hospital because of dysphagia. Cervical esophageal carcinoma was found to have invaded the larynx through endoscopy, and invasion to thyroid gland and trachea was suspected from a cervical CT. We diagnosed the condition as advanced esophageal carcinoma (A2N(-)M0Pl0 Stage III). We then treated the patient by chemoradiation therapy. After the treatment, the carcinoma could not be detected by CT and endoscopy, and endoscopic biopsy revealed there were no active carcinoma cells. The side effects of the therapy were very mild, therefore the patient could be discharged after a short time. No evidence of a tumor relapse was found 5 months after the therapy. We treated 4 patients with esophageal carcinoma using the same regimen, and the results of the therapy were 2 CR, 1 PR, and 1 PD, with an overall response rate of 75%.     

低剂量顺铂联合5-氟尿嘧啶周疗同步放疗治疗中晚期宫颈癌

目的 评价低剂量顺铂(DDP)+5-氟尿嘧啶(5-Fu)周疗同步放疗治疗中晚期宫颈癌的疗效和不良反应.方法 73例中晚期宫颈癌患者随机分为化放组(37例)和单放组(36例).化放组放疗同期每周接受1次DDP 40 mg+5-FU 500 mg化疗,连用6～7周;单放组行单纯放疗.两组放疗均采用常规分割,总剂量50 Gy.结果 化放组与单放组总有效率、3年生存率、局部复发率、远处转移率分别为97.30%和77.78%、89.19%和66.67%、8.11%和30.56%、10.81%和33.33%,两组对比差异均有统计学意义(P<0.05),骨髓抑制及消化道反应发生率化放组均高于单放组,多为Ⅰ、Ⅱ级.结论 低剂量DDP+5-FU周疗同步放疗治疗中晚期宫颈癌可显著提高患者的局部控制率和生存率,不良反应轻.     

Clinical evaluation of combination chemotherapy of aclacinomycin A (ACM) and 5-fluorouracil (5-FU) for advanced carcinoma of gastrointestinal tract

Clinical evaluation of the combination chemotherapy of ACM and 5-FU(AF therapy) for patients with far-advanced, recurrent and inoperable gastric and colorectal carcinomas was made by the study group composed of 13 major hospitals in Tohoku area. Fifty-nine patients were treated with this regimen and 41 (gastric carcinoma 32 cases, colorectal carcinoma 8 cases and bile duct carcinoma 1 case) were evaluable. The schedule of treatment was as follows: 40mg of ACM was given twice a week (the 1st and 4th days) by intravenous one-shot injection along with 250mg of 5-FU everyday by intravenous drip infusion. No patients received anti-cancer drugs and radiation therapy for one month before AF therapy. As to the clinical efficacy, 32 patients with gastric carcinoma showed a relatively good response rate of 3% on CR and 22% on PR by Koyama and Saito's criteria. The rate that showed more than I-A by Karnofsky's criteria was 38%. The clinical effects on patients with colorectal carcinoma or bile duct carcinoma were negligible. As to the histological types, 16 cases with poorly-differentiated gastric carcinoma showed a response rate of 6% on PR, but 16 patients with well a differentiated gastric carcinoma showed that of 38% of PR and 6% of CR. The effective cases were more frequently observed in well-differentiated carcinoma than poorly-differentiated carcinoma. The major side effects of AF therapy were bone marrow suppression and gastrointestinal toxicity. The former was observed in 45% of all patients and the latter in 27% of them. Hepatic toxicity, abnormal change of ECG and hemorrhagic diathesis were not observed.     

Sequential chemotherapy with low-dose methotrexate and 5-fluorouracil in advanced gastric cancer

Sequential chemotherapy with low-dose methotrexate (30 mg/body) and 5-FU (750 mg/m2) was undertaken in 16 patients with advanced gastric cancer. Following the chemotherapy, leucovorin (30 mg/body) was injected intravenously. These treatment were repeated weekly for two to eight weeks. Out of 16 patients, two partial remissions and two minor responses were obtained. The overall response rate was 12.5%. There were no cases of renal or hematologic toxicity. The only adverse effect was nausea. We concluded therefore, that sequential chemotherapy with low-dose methotrexate and 5-FU is a useful method for advanced gastric cancer.     

Outpatient chemotherapy with infusional 5-fluorouracil in advanced gastrointestinal cancer

These studies were designed to evaluate the efficacy, toxicity, and resulting quality of life (QOL) of outpatient chemotherapy with infusional 5-FU for advanced gastrointestinal cancer. Schedule, sch. A: Treatment consisted of CI 5-FU 200 mg/m2/day, days 1-28, IVB Leucovorin 20 mg/m2 q week. Fifteen patients with advanced gastrointestinal cancer were treated to maintain the efficacy of prior inpatient chemotherapy. Twenty-one patients treated with adjuvant chemotherapy were added to evaluate toxicity and QOL. The mean time to progression (TTP) was 2.6 months. Grade 2 toxicities were seen, including mucositis (23%) and diarrhea (7%). Hand-foot syndrome was seen 60% of patients. The mean QOL score was 89.5 +/- 7.8. Sch.B: Treatment consisted of weekly 24 h infusion of 5-FU 2,600 mg/m2. 5-FU was administered using a Groshong catheter and Baxter infusor LV5 (5 ml/hr). Nine patients with advanced gastrointestinal cancer were treated. Twenty-one patients were treated with adjuvant chemotherapy. The mean TTP was 3.6 month. Grade 2 toxicities were seen, including leucocytopenia (7%), mucositis (3%), diarrhea (10%), and nausea and vomiting (10%). The mean QOL score was 82.6 +/- 10.7. In conclusion, both 5-FU schedules are feasible for outpatient chemotherapy for advanced gastrointestinal cancer.     

A case of hepatocellular carcinoma responding to hepatic arterial infusion chemotherapy with low-dose cisplatin and 5-fluorouracil]

A 74-year-old man had multiple liver recurrence of hepatocellular carcinoma (HCC) after extended left hepatectomy. He was treated by continuous hepatic arterial infusion (HAI) chemotherapy with low-dose cisplatin (CDDP) and 5-fluorouracil (5-FU) via an implanted reservoir. A catheter was inserted percutaneously into the hepatic artery using the Seldinger technique. The patient was administered 10 mg of CDDP on day 1 and 500 mg/day of 5-FU for 4 days as one course. Four courses were administered and the PIVKA-II level decreased from 427 to 216 mAU/ml. However, infusion port problems led to interruption of chemotherapy and PIVKA-II increased to 798 mAU/ml. His chemotherapy was changed to 10 mg of CDDP on day 1 and 750 mg/day of 5-FU for 2 days. After five courses were administered, PIVKA-II decreased to 540 mAU/ml. This patient is still alive 15 months after the start of therapy. This case suggests that HAI with low-dose CDDP and 5-FU might be useful for prolonging the survival of HCC patients with a good quality of life.     

Treatment for advanced colorectal carcinoma with 5-fluorouracil plus low-dose leucovorin]

From July 1992 to May 1996, 16 patients with non-curative postoperative or recurrent colorectal carcinomas were treated with 5-fluorouracil (5-FU) plus leucovorin (LV) systemic chemotherapy. LV was given at a dose of 20 mg/m2/d immediately followed by 5-FU at 370 mg/m2/d. LV was given by rapid intravenous (i.v.) injection and 5-FU by rapid or drip i.v. for 5 consecutive days. Courses were repeated once every 4 weeks for two months and then once every 5 weeks. All patients took 3 or more courses. The toxicity was tolerable, but one patient needed hospitalization because of severe gastro-intestinal toxicity. We observed 3 PR cases, no CR and an overall response rate of 19%. The response duration was 6 to 8 months, averaging 7.3 months, and median survival was 12 months. It was possible to perform this chemotherapy on an outpatient basis, so we think this chemotherapy is superior to in-hospital chemotherapy considering the issue of quality of life. However, the response rate was low and its duration was short. We must investigate chemotherapy further with new and more powerful chemical modulations to increase the response rate and to prolong the response duration.     

Liposomal paclitaxel versus docetaxel in induction chemotherapy using Taxanes,cisplatin and 5-fluorouracil for locally advanced nasopharyngeal carcinoma

Background

We wished to evaluate the efficacy and safety of liposomal paclitaxel and docetaxel for induction chemotherapy (IC) for nasopharyngeal carcinoma (NPC).

Methods

A total of 1498 patients with newly-diagnosed NPC between 2009 and 2017 treated with IC plus concurrent chemotherapy were included in our observational study. Overall survival (OS), progression-free survival (PFS), locoregional relapse-free survival (LRFS), distant metastasis-free survival (DMFS) and grade-3–4 toxicities were compared between groups using propensity score matching (PSM).

Results

In total, 767 patients were eligible for this study, with 104 (13.6%) and 663 (86.4%) receiving a liposomal paclitaxel-based and docetaxel-based taxanes, cisplatin and 5-fluorouracil (TPF) regimen, respectively. PSM identified 103 patients in the liposomal-paclitaxel group and 287 patients in the docetaxel group. There was no significant difference at 3?years for OS (92.2% vs. 93.9%, P?=?0.942), PFS (82.6% vs. 81.7%, P?=?0.394), LRFS (94.7% vs. 93.3%, P?=?0.981) or DMFS (84.6% vs. 87.4%, P?=?0.371) between the two groups after PSM. Significant interactions were not observed between the effect of chemotherapy regimen and sex, age, T stage, N stage, overall stage, or Epstein–Barr virus DNA level in the subgroup multivariate analysis. The prevalence of grade-3–4 leukopenia and neutropenia in the liposomal-paclitaxel group was significantly lower than that of the docetaxel group (P?<?0.05 for all).

Conclusions

Compared with docetaxel, liposomal paclitaxel has identical anti-tumor efficacy, but causes fewer and milder adverse reactions in IC for NPC.