ABSTRACT
Objective This study was conducted to evaluate treatment-related toxicities,the patterns of failure,overall survival(OS)and progression-free survival(PFS)by comparing IFI with ENI in combination with chemotherapy. Methods Eligible patients were treated with concurrent chemoradiotherapy and randomized into either an IFI or ENI arm. The primary end points wereacute treatment-related toxicities. The secondary end points were patterns of failure,OS and PFS. Kaplan?Meier survival rate of the method for calculating the Logrank test difference method. Results Between April 2012 and October 2016,a total of 228 patients were enrolled from nine centers in china. Grade≥3,Grade≥2 radiation esophagitis and pneumonitis in the IFI arm were significantly lower than that of the ENI arm(P=0.018,0.027).No significant differences were observed in overall failure rates,loco-regional failure,distant failure rates,in-field and out-field lymph node failure between the two arms(P=0.401,0.561,0.510,0.561,0.681).The 1-,2-, 3-,4-yearand median OS in the ENI arm and IFI arm were 84.1%,57.3%,39.4%,31.6%,28 months and 83.6%,62.1%,44.5%,31.5%,32 months(P=0.654),respectively. The 1-,2-,3-yearand median PFS in the ENI arm and IFI arm were 71.9%,42.3%,32.7%,20 months and 70.1%,45.0%,35.9%,22 months (P=0.885),respectively. Conclusions Compared to ENI,IFI resulted in decreased radiation pneumonitis and esophagitis without sacrificing loco-regional lymph nodal control,PFS and OS in thoracic ESCC. Clinical Trial Registry Chinese Clinical trail registry,registration number:NCT01551589.
ABSTRACT
Objective To evaluate the safety and efficacy of induction chemotherapy with gemcitabine followed by concurrent chemoradiotherapywith capecitabine in patients with locally advanced pancreatic cancer (LAPC).Methods A total of 42 patients with locally advanced pancreatic cancer were enrolled.All patients received seven cycles of induction chemotherapy of gemcitabine 1 000 mg/m2,once a week.Concurrent chemoradiotherapy began 1 week after completion of induction chemotherapy.Radiotherapy was delivered with a median dose of 54 Gy (34-64 Gy) with 1.8-2.0 Gy in a fraction.The radiotherapy was combined with capecitabin at a dosage of 825 mg/m2 twice daily,5 d/week.Results Twenty patients (47.6％) were evaluated as clinical benefit response (CBR).Two cases were observed with complete remission (CR),8 with partial remission (PR),27 with stable disease (SD),and 5 with progressive disease (PD).The median overall survival was 10.1 months (range of 4-36 months).The 1-,2-year overall survival rate was 38.2％ and 18.2％,respectively.Myelosuppression was recorded in 20 patients with grades 1-2,and 5 patients with grade 3.Twenty-two patients suffered from grade 1-2 gastrointestinal toxicities,while 4 patients suffered from grade 3.Conclusions The preliminary results showed that induction chemotherapy with gemcitabine followed by concurrent chemoradiotherapy with capecitabine in patients with LAPC might achieve encouraging efficacy with better tolerance.
