Comparison of induction chemotherapy with docetaxel, cisplatin, and 5-fluorouracil (TPF) followed by radiation vs concurrent chemoradiotherapy with TPF in patients with locally advanced squamous cell carcinoma of the head and neck

AimsTo compare the effectiveness of induction chemotherapy with docetaxel, cisplatin and 5-fluorouracil (TPF) followed by radiation with that of concurrent chemoradiotherapy with TPF in patients with locally advanced squamous cell carcinoma of the head and neck (SCCHN).Materials and methodsIn a group of patients receiving induction chemotherapy followed by radiation, 15 patients received two cycles of chemotherapy with docetaxel 60 mg/m², cisplatin 70 mg/m² and 5-day 5-fluorouracil (5-FU) 750 mg/m²/day. Radiotherapy was begun 21 days after completing chemotherapy. In the group receiving concurrent chemoradiotherapy, 19 patients received two cycles of chemotherapy with docetaxel 50 mg/m², cisplatin 60 mg/m², and 5-day 5-FU 600 mg/m²/day. Radiation was begun on the first day of chemotherapy. The total radiation dose was between 63 and 74 Gy.ResultsOverall response rate (partial and complete response — both 100%) and complete response rate (87% and 84%) were similar, but, in overall survival, concurrent chemoradiotherapy with TPF was better than induction chemotherapy with TPF followed by radiation. Mucositis and anaemia were more frequent in the group receiving concurrent chemoradiotherapy, but the group receiving concurrent chemoradiotherapy with TPF improved overall survival.ConclusionsThis is a small non-randomised comparison. The effectiveness of concurrent chemoradiotherapy with TPF was better than that of induction chemotherapy with TPF followed by radiation.     

Induction chemotherapy with docetaxel,cisplatin and 5-fluorouracil followed by radiotherapy with cetuximab for locally advanced squamous cell carcinoma of the head and neck

PurposeTo determine the efficacy and feasibility of induction chemotherapy (ICT) with docetaxel, cisplatin and 5-fluorouracil followed by radiotherapy and cetuximab (C) in patients with locally advanced head and neck cancer.Patients and methodsForty-nine previously untreated patients with local advanced stage III and IV squamous cell carcinoma of the head and neck (SCCHN) received three courses of ICT consisting of docetaxel 75 mg/m² day 1, cisplatin 75 mg/m² day 1 and infusional 5-fluorouracil 750 mg/m²/day on days 1–5 followed by radiotherapy plus C at 250 mg/m²/week (after an initial loading dose of 400 mg/m²).ResultsAfter completion of ICT 44 of 49 patients received radiotherapy plus C. Three months after therapy completion tumour response was observed in 33 patients and after two years, 25 patients were in complete remission (CR). The most common grade 4 toxicity during the whole treatment period was dermatitis (30%), followed by mucositis (27%) and neutropenia (17%) without fever. One toxic related death was observed during ICT. Two-year progression-free survival (PFS) rate was 59% and two-year overall survival (OS) rate was 63%, respectively.ConclusionConcurrent radiotherapy plus C after three courses of ICT was feasible and was associated with promising CR, PFS and OS rates. Further optimisation of dose and sequence is warranted.     

TPF方案诱导化疗加同期顺铂化放疗治疗晚期鼻咽癌的临床研究

 目的　探讨多西紫杉醇（TAX）、顺铂（DDP）、5-氟尿嘧啶（5-Fu）三药联合方案诱导化疗加DDP同期放化疗治疗晚期鼻咽癌的近期疗效及可行性。方法　40例初诊局部晚期（UICC分期Ⅲ、Ⅳ期）鼻咽癌患者入组,随机分为诱导化疗加DDP 3周方案组（A组）,诱导化疗加DDP单周方案组（B组）。两组均先行2个疗程诱导化疗,方案为TAX 60 mg／m2第1天;DDP 60 mg／m2第1天;5-Fu 600 mg／m2 第1天至第5天,每3周重复,共2个周期。第7周开始放疗,放疗第1天同时行化疗。A组：DDP 80 mg／m2第1天,每3周1次,共2次;B组： DDP 30 mg／m2第1天,每周1次,共6次。放疗采用二维适形照射,鼻咽原发病灶68～72 Gy,34～36次,7周,颈部淋巴结阳性区60～66 Gy,30～33次,6～6.5周。结果　40例共完成78个疗程诱导化疗,A、B组各1例出组。38例可评价疗效和不良反应。A组17例完成2个疗程同期DDP化疗;B组10例按计划完成6个周同期化疗,4例完成5周化疗,4例完成4周化疗,1例只完成2周化疗。诱导化疗后CR 4例（10.5 %）,PR 27例（71.1 %）,SD 7例（18.4 %）,总有效（CR+PR）率81.6 %。治疗结束后CR 32例（84.2 %）,PR 5例（13.2 %）,SD 1例（2.6 %）,总有效率 97.4 %。结论　TPF诱导化疗加DDP同期放化疗是治疗晚期鼻咽癌的可行方案,推荐使用同期DDP 3周化疗方案。剂量强度可否提高,有待进一步研究。     

TP诱导联合DDP同期放化疗治疗局部晚期食管癌临床研究

  目的  研究不适手术的局部晚期食管癌患者行TP方案诱导化疗联合DDP同期放化疗的毒性及疗效。  方法  33例胸段食管鳞癌T₃N₀M_O~T₄N₂M₀期患者（不包括腹腔淋巴结转移）,第1天和第22天行TP方案诱导化疗,多西他赛（艾素）75 mg/m2, DDP 75 mg/m2。第43天开始放疗,采用三维适形放疗,总剂量60 Gy,2 Gy/次,5次/周。同期化疗:DDP 30 mg/m2,1次/周,放疗开始的第1、8、15、22、29、36天给药。  结果  诱导化疗Ⅳ级骨髓毒性为12.12%（4/33）,无Ⅲ级或以上的肝、肾毒性。同期放化疗骨髓毒性最高为Ⅲ级,红细胞、粒细胞、血小板Ⅲ级毒性分别为21.21%（7/33）、15.15%（5/33）、3.03%（1/33）,无Ⅱ级以上的肝肾毒性。Ⅲ级放射性食管炎为9.10%（3/33）,未发现Ⅲ级以上的放射性食管炎及Ⅰ级以上的急性放射性肺炎。治疗结束评价显效（CR+PR）84.85%（28/33）,稳定（SD）12.12%（4/33）,进展（PD）3.03%（1/33）;治疗后2个月评价显效（CR+PR）75.76%（25/33）,稳定（SD）9.10%（3/33）,进展（PD）15.15%（5/33）。全组死亡病例15例。1年生存率66.4%,最主要失败模式是局部失败46.67%（7/15）,局部+远处失败26.67%（4/15）。  结论  局部晚期食管癌患者行TP方案诱导化疗+DDP同期放化疗的毒性可以耐受,局部失败仍然是主要的失败模式。      

Preoperative docetaxel/cisplatin/5-fluorouracil chemotherapy in patients with locally advanced gastro-esophageal adenocarcinoma

Perioperative chemotherapy plus surgery improves survival compared to surgery alone in GE junctional (GEJ) and gastric adenocarcinomas. The docetaxel/cisplatin/5-fluorouracil (DCF) combination is superior to CF in patients with metastatic gastric cancer. We retrospectively evaluated the safety and efficacy of preoperative DCF chemotherapy in patients with locally advanced gastric and GEJ cancer. Twenty-one gastric and 10 gastroesophageal junctional (GEJ) cancer patients received 2-3 cycles of preoperative docetaxel 75 mg/m(2) and cisplatin 75 mg/m(2) on day 1, 5-FU 750 mg/m(2) (continuous infusion) on days 1-5 every 3 weeks. Clinical response was evaluated by comparing pre- and postchemotherapy CT scans. Overall survival (OS) and progression-free survival (PFS) were calculated from the initiation of chemotherapy. None of the patients achieved complete clinical remission while 11 (35%) patients achieved partial clinical remission. Ten patients with GEJ cancer (100%) and 13 with gastric cancer (62%) underwent curative surgery (P = 0.023). Seventeen (55%) patients experienced grade 3-4 chemotherapy-related adverse events. The most common adverse events were anemia, nausea/vomiting, diarrhea, and febrile neutropenia. At a median follow-up of 17.0 months, median OS and PFS were 26.1 months (95% CI: 22.7-29.5) and 18.8 months (95% CI: 9.9-27.7), respectively. The DCF regimen is active in patients with gastric and GEJ adenocarcinoma in the preoperative setting.     

多西他赛加顺铂诱导化疗联合同期放化疗局部晚期非小细胞肺癌的临床观察

目的 评价TP方案诱导化疗联合同期放化疗局部晚期非小细胞肺癌的近期疗效和不良反应。方法 病理证实的局部晚期非小细胞肺癌86例,随机分成同期放化疗联合TP方案诱导化疗(ICCRT) 组和单纯同期放化疗(CCRT) 组。放疗均采用调强放疗。治疗结束后比较两组疗效、生存率和不良反应。结果 86例患者的随访率为100%。ICCRT组和CCRT组的有效率分别为80%和70%(χ²=1.26,P=0.261),1、2、3年总生存率分别为85%和65%、50%和40%、44%和33%(χ²=3.90,P=0.048),主要不良反应白细胞减少(43例和32例,χ²=3.48,P=0.062)、放射性食管炎(26例和20例,χ²=0.12,P=0.730)、血红蛋白减低(26例和16例,χ²=2.34,P=0.126)和放射性肺炎(13例和9例,χ²=0.37,P=0.541)。结论 ICCRT能明显提高局部晚期非小细胞肺癌的总生存率,且与CCRT相比并不增加局部不良反应。     

Docetaxel,cisplatin and 5-fluorouracil-based induction chemotherapy followed by intensity-modulated radiotherapy concurrent with cisplatin in locally advanced EBV-related nasopharyngeal cancer

BackgroundThis monocentric study evaluates the activity and tolerability of docetaxel (Taxotere), cisplatin and 5-fluorouracil (5-FU) (TPF) induction chemotherapy followed by intensity-modulated radiotherapy (IMRT) concurrent with high-dose cisplatin in Epstein–Barr virus -related locally advanced undifferentiated nasopharyngeal cancer.Patients and methodsWe retrospectively reviewed the records of patients who received induction docetaxel 75 mg/m² and cisplatin 75 mg/m² on day 1, and 5-FU 750 mg/m²/day (96-h continuous infusion). Following induction, patients received full doses of IMRT concurrently with cisplatin 100 mg/m² every 21 days for three cycles.ResultsThirty patients received three TPF cycles (median). Induction was well tolerated; the main toxicity was neutropenia (33%, grade 3–4). During chemoradiotherapy, neutropenia (40%) and mucositis (43%) were the most frequent grade 3–4 adverse events. Mean dose of IMRT was 68.8 Gy. Worst late toxicity was xerostomia. Complete response rate was 93%. At 35 months, two patients had locoregional recurrence, three had distant metastases, and one had both. Three-year progression-free survival and overall survival were 79% [95% confidence interval (CI) 64% to 94%] and 87% (95% CI 74%– to 100%), respectively.ConclusionsIn this high-stage nonendemic cancer population, TPF followed by high-dose cisplatin IMRT was promising; this treatment approach deserves evaluation in randomized trials.     

Comparison of hyperfractionation and conventional fractionation radiotherapy with concurrent docetaxel, cisplatin and 5-fluorouracil (TPF) chemotherapy in patients with locally advanced squamous cell carcinoma of the head and neck (SCCHN)

Purpose Radiotherapy (RTx) has been considered as the treatment for locally advanced squamous cell carcinoma of the head and neck (SCCHN). However, with only conventional fractionation (Cfx), response rates are relatively low. In this study, we report the results of hyperfractionation (Hfx) RTx with concurrent docetaxel, cisplatin and 5-fluorouracil (TPF) chemotherapy (CTx) in patients with locally advanced SCCHN and compare Hfx and Cfx RTx with concurrent TPF CTx. Methods Fifty patients with previously untreated stage III–IV SCCHN were entered into this study. Eligible patients received RTx delivered using arm 1: Hfx at 1.2 Gy/fraction, twice daily, 5 days/week to 76.8 Gy/64 fractions, and arm 2: Cfx at 2 Gy/fraction/day, 5 days/week to 70 Gy/35 fractions. Patients received 2 cycles CTx every 4 weeks. The doses were docetaxel 50 mg/m² (day 1), cisplatin 60 mg/m² (day 4), and 5-FU 600 mg/m²/day (days 1–5). Results The overall clinical response rate and the pathological CR were 100% (25/25) and 84% (21/25) in arm 1, and 100% (25/25) and 80% (20/25) in arm 2. Local–regional control was better significant in arm 1 than arm 2 (P = 0.048). There were also trend toward improved disease-free survival (P = 0.059) and overall survival (P = 0.078) in arm 1. Mucositis was significantly more frequent in arm 1 (P = 0.048). Conclusion There were trend toward improved local–regional control, disease-free survival and overall survival in Hfx RTx with concurrent TPF CTx, compared to Cfx RTx with concurrent TPF CTx.     

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.

     

紫杉醇联合顺铂、5-氟尿嘧啶(TPF方案)新辅助化疗治疗晚期鼻咽癌的临床分析

目的:评价紫杉醇联合顺铂(DDP)、5-氟尿嘧啶(5-FU)(TPF方案)治疗晚期鼻咽癌的疗效和不良反应.方法:Ⅲ-Ⅳa 期鼻咽癌患者98例随机分为紫杉醇+顺铂+5-氟尿嘧啶新辅助化疗联合同期放化疗(治疗组)及以5-氟尿嘧啶+顺铂组成的同期放化疗组(对照组).新辅助化疗药用量:紫杉醇 135mg/m2,d1,顺铂20mg/m2,d1-5,5-氟尿嘧啶750mg/ m2,d1-5,每21天重复,治疗组所有病人均接受两个疗程TPF方案新辅助化疗.第2程新辅助化疗后14天即开始放疗.两组同期放疗相同.放疗采取 6MV X线常规照射,鼻咽部总剂量约 DT 70Gy/49天,颈部预防剂量约 DT 50-55Gy/35-42天,治疗剂量约 60-70 Gy/42-49天.比较两组疗效及不良反应.结果:治疗组鼻咽及颈部肿瘤消失的平均剂量小于对照组(P＜0.05) ;两组肿瘤临床全消率分别为87.8%与77.6%(P＜0.01).不良反应主要为粒细胞下降、脱发、口腔黏膜反应及胃肠道反应,均能耐受.结论:紫杉醇联合顺铂、5-氟尿嘧啶新辅助化疗治疗晚期鼻咽癌可提高肿瘤消失率,是治疗晚期鼻咽癌有效安全的方案.     

TP方案诱导化疗后同期TP与DDP治疗局部晚期鼻咽癌的对照研究

背景与目的：以往多西紫杉醇（docetaxel）联合顺铂（cisplatin,DDP）（TP方案）治疗鼻咽癌的临床试验的样本量小,得出的结果不一。本研究比较TP方案诱导化疗后TP与DDP同期放化疗在局部晚期鼻咽癌治疗中的近期疗效、不良反应。方法：57例初治鼻咽癌患者随机分为两组：同期TP方案放化疗组（TP组）30例：同期DDP放化疗组（DDP组）27例。两组诱导化疗采用TP方案（Docetaxel 70mg／m^2第11天,DDP80mg／m^2 d1）,每3周1次,共2周期。同期化疗（每3周1次,共2周期）：TP组采用TP方案（Docetaxel 60mg／m^2 d1,DDP80mg／m^2 d2）：DDP组采用DDP80mg／m^2 d1。照射野采用CT-Sim设计,常规分割放疗。结果：57例患者完成诱导化疗111周期;53例患者完成同期化疗103周期。诱导化疗终止4例,同期化疗终止3例。所有入组患者都完成放疗。诱导化疗不良反应主要为血液毒性,同期放化疗不良反应主要为血液毒性和口腔粘膜反应。TP组3～4度白细胞减少、3—4度中性粒细胞减少的发生率明显高于DDP组,差异有统计学意义（P〈0．005）。同期放化疗中,TP组患者100％使用G—CSF,明显高于DDP组（72．0％）,两组比较差异有统计学意义（P〈0．005）。同期放化疗后鼻咽部病灶完全缓解率：TP组93．3％,DDP组96．3％：区域淋巴结完全缓解率：TP组92．9％,DDP组91．3％。两组肿瘤反应比较差异无统计学意义。结论：TP方案诱导化疗后．TP同期放化疗的肿瘤缓解率与DDP同期放化疗相似。TP同期放化疗的不良反应发生比DDP同期放化疗高,但在G—CSF支持下,患者能耐受。TP方案的远期疗效值得进一步临床探讨。     

Multicenter phase II trial of preoperative induction chemotherapy followed by chemoradiation with docetaxel and cisplatin for locally advanced esophageal carcinoma (SAKK 75/02)

BackgroundThis multicenter phase II study investigated the efficacy and feasibility of preoperative induction chemotherapy followed by chemoradiation and surgery in patients with esophageal carcinoma.Patients and methodsPatients with locally advanced resectable squamous cell carcinoma or adenocarcinoma of the esophagus received induction chemotherapy with cisplatin 75 mg/m² and docetaxel (Taxotere) 75 mg/m² on days 1 and 22, followed by radiotherapy of 45 Gy (25 × 1.8 Gy) and concurrent chemotherapy comprising cisplatin 25 mg/m² and docetaxel 20 mg/m² weekly for 5 weeks, followed by surgery.ResultsSixty-six patients were enrolled at eleven centers and 57 underwent surgery. R0 resection was achieved in 52 patients. Fifteen patients showed complete, 16 patients nearly complete and 26 patients poor pathological remission. Median overall survival was 36.5 months and median event-free survival was 22.8 months. Squamous cell carcinoma and good pathologically documented response were associated with longer survival. Eighty-two percent of all included patients completed neoadjuvant therapy and survived for 30 days after surgery. Dysphagia and mucositis grade 3/4 were infrequent (<9%) during chemoradiation. Five patients (9%) died due to surgical complications.ConclusionsThis neoadjuvant, taxane-containing regimen was efficacious and feasible in patients with locally advanced esophageal cancer in a multicenter, community-based setting and represents a suitable backbone for further investigation.     

TPF方案诱导化疗对局部N晚期鼻咽癌的近期疗效

 目的　比较1个疗程TPF方案和2个疗程PF方案作为诱导化疗对局部N晚期鼻咽癌的近期疗效和患者不良反应。方法　收集2007年1月至2008年12月初治的47例接受过诱导化疗的局部N晚期鼻咽癌患者,其中采用1个疗程TPF诱导化疗方案26例,采用2个疗程PF诱导化疗方案21例; TPF方案使用多西紫杉醇（Docetaxel,TAX,商品名：泰素帝） 60 mg／m2,静脉滴注,第1天;顺铂（DDP）80 mg／m2,静脉滴注,第1天;5-氟尿嘧啶（5-Fu） 800 mg／m2,第1天至第4天,静脉泵注。PF方案使用DDP 100 mg／m2,静脉滴注,第1天;5-Fu 1000 mg／m2,第1天至第4天,静脉泵注;两组均为3周方案。随后两组均采用DDP（30 mg／m2,每周方案）单药为基础的同期放化疗。观察比较两组患者的近期疗效和不良反应。结果　试验组诱导化疗后鼻咽部病灶有效率（CR+PR）57.7 %;颈部有效率69.2 %,对照组2个疗程PF方案诱导化疗后鼻咽部病灶有效率66.7 %;颈部有效率71.4 %（P＞0.05）。治疗后3个月试验组鼻咽部病灶和颈部淋巴结CR率分别为 92.3 %和88.7 %,而对照组鼻咽部病灶和颈部淋巴结CR率分别为 100.0 %和90.5 %（P＞0.05）。试验组治疗不良反应主要是中性粒细胞减少和脱发。结论　1个疗程TPF诱导化疗对局部N晚期鼻咽癌可取得较好的局部控制率,中性粒细胞减少是主要的治疗毒性。     

DCF (docetaxel,cisplatin and 5-fluorouracil) chemotherapy is a promising treatment for recurrent advanced squamous cell anal carcinoma

BackgroundSquamous cell carcinoma of the anal canal (SCCA) is a rare disease, mostly diagnosed at early stage. After concurrent chemoradiation (CRT) with mitomycin C and 5-fluorouracil (5FU), local or metastatic recurrences occur in >20% of the patients. After treatment failure, cisplatin (CDDP)-based chemotherapy is the standard option, but complete response (CR) is a rare event and the prognosis remains poor.Patients and methodsEight consecutive patients with advanced recurrent SCCA after CRT were treated with DCF regimen (docetaxel 75 mg/m² day 1, CDDP 75 mg/m² day 1 and 5FU at 750 mg/m²/day for 5 days every 3 weeks). Tumour samples were analysed for human papillomavirus (HPV) genotyping, as well as p16 and p53 expression.ResultsAfter a median follow-up of 41 months, the overall survival rate at 12 months was 62.5% (95% CI 22.9–86.1 months). Four patients achieved a complete remission and remain relapse-free at the time of analysis with a progression-free survival of 19, 33, 43 and 88 months. Three of these patients underwent surgery for all involved metastatic sites. For all of them, pathological CR was confirmed. DCF regimen appeared feasible in these patients previously exposed to pelvic CRT, and no grade IV toxicity occurred. All patients in complete remission had HPV-16-positive SCCA, while HPV could only be detected among 50% of the non-responding patients. Of interest, immunohistochemical study revealed a p16⁺/p53^- phenotype in these patients, while none of non-responders expressed p16.ConclusionThe high level of complete and long-lasting remission among SCCA patients treated with DCF regimen supports the assessment of this strategy in prospective cohorts.     

Long-term results of a randomized phase III trial of TPF induction chemotherapy followed by surgery and radiation in locally advanced oral squamous cell carcinoma

Previously, we conducted a randomized phase III trial of TPF (docetaxel, cisplatin, and 5-fluorouracil) induction chemotherapy in surgically managed locally advanced oral squamous cell carcinoma (OSCC) and found no improvement in overall survival. This study reports long-term follow-up results from our initial trial. All patients had clinical stage III or IVA locally advanced OSCC. In the experimental group, patients received two cycles of TPF induction chemotherapy (75mg/m² docetaxel d1, 75mg/m² cisplatin d1, and 750mg/m²/day 5-fluorouracil d1-5) followed by radical surgery and post-operative radiotherapy; in the control group, patients received upfront radical surgery and post-operative radiotherapy. The primary endpoint was overall survival. Among 256 enrolled patients with a median follow-up of 70 months, estimated 5-year overall survival, disease-free survival, locoregional recurrence-free survival, and distant metastasis-free survival rates were 61.1%, 52.7%, 55.2%, and 60.4%, respectively. There were no significant differences in survival rates between experimental and control groups. However, patients with favorable pathologic responses had improved outcomes compared to those with unfavorable pathologic responses and to those in the control group. Although TPF induction chemotherapy did not improve long-term survival compared to surgery upfront in patients with stage III and IVA OSCC, a favorable pathologic response after induction chemotherapy may be used as a major endpoint and prognosticator in future studies. Furthermore, the negative results observed in this trial may be represent type II error from an underpowered study. Future larger scale phase III trials are warranted to investigate whether a significant benefit exists for TPF induction chemotherapy in surgically managed OSCC.     

Simultaneous radiotherapy and chemotherapy with 5-fluorouracil and cisplatin for locally confined squamous cell head and neck cancer

Fifty-four patients with previously untreated or minimally treated locally confined (MO) squamous cell carcinoma of the head and neck were treated with chemoradiotherapy employing multiple courses of simultaneous radiation, cisplatin, and a 4-day 5-fluorouracil infusion. Twenty-eight patients subsequently underwent definitive surgery, and 26 were treated without surgical resection. Of the 54 patients, 51 were ultimately rendered disease free by this combined modality protocol. The projected relapse-free survival rate for the entire cohort is 71%, with a median relapse-free survival time greater than 17 months. Thirteen patients who had tumors that were technically operable did not undergo surgery after achieving a complete response to induction chemoradiotherapy. Only 1 of these patients experienced subsequent local failure. Although the treatment-associated mucositis and local failure. Although the treatment-associated mucositis and myelosuppression were significant, this chemoradiotherapeutic protocol offers a significant chance of relapse-free survival for all patients with locally confined disease and merits comparison with more standard treatment approaches.     

Induction chemotherapy with cisplatin/docetaxel versus cisplatin/5-fluorouracil for locally advanced squamous cell carcinoma of the head and neck: a randomised phase II study

A combination of cisplatin and 5-fluorouracil (PF) is considered the standard induction chemotherapy regimen for squamous cell carcinoma of the head and neck (SCCHN). The present study compares the efficacy and safety of a new combination of cisplatin/docetaxel versus the PF regimen. A total of 83 chemotherapy-naive patients with locally advanced SCCHN were randomised to receive every 21 d (i) docetaxel 85 mg/m2 i.v. on day 1 and cisplatin 40 mg/m2 i.v. on days 1 and 2 (arm A) or (ii) cisplatin 100 mg/m2 i.v. on day 1 followed by 5-fluorouracil 1000 mg/m2 in 24 h continuous infusion for 5 d (arm B). A total of 287 cycles (range 1-3 per patient) were administered. Among 76 patients evaluable for response, the overall response rate in arm A was 70% (complete response (CR) 26%, partial response (PR) 44%) and in arm B 69% (CR 16%, PR 54%), respectively. Median survival in arm A was 7.6 months (95% CI: 5.8-11.1) and 9.9 months (95% CI: 7.4-14.6) for arm B. The most frequent grade 3/4 toxicity in arm A was neutropaenia (34.1%) and diarrhoea (9.8%) versus mucositis (29.3%) and neutropaenia (19.5%) in arm B. Both schedules present a similar efficacy, with different but acceptable toxicity patterns.