BACKGROUND: We designed a phase II trial to examine the benefit of preoperative hyperfractionated radiation therapy (XRT) and concurrent chemotherapy for patients with locally advanced esophageal cancer (LAEC). AIM OF STUDY: The pathologic complete response (pCR) was the primary endpoint to estimate efficacy. METHODS: Twenty-three patients with LAEC received twice-daily XRT during wk 1 and 5 and once-daily XRT during wk 2-4 (59 Gy). Cisplatin (100 mg/m(2)) was given on d 1, while 5-fluorouracil (1000 mg/m(2)) was given by continuous infusion the first and fifth weeks of the XRT. RESULTS: The pCR for the 19 patients undergoing esophagectomy was 16%. The study was closed at the interim analysis having not met the required minimum pCR rate of 20%. Hematologic toxicities consisted of grades III and IV neutropenia observed in 33% and 14% of patients, respectively. Grade III nausea and vomiting was seen in 38% of patients. One grade V pulmonary toxicity occurred. The median survival was 44.6 mo with 65% of patients alive at 2 yr. CONCLUSIONS: The pCR rate in this trial did not meet the predetermined statistical minimum. With the encouraging 2-yr survival, it is not clear that pCR is a reliable surrogate endpoint to discern treatment efficacy.
BACKGROUND: We designed a phase II trial to examine the benefit of preoperative hyperfractionated radiation therapy (XRT) and concurrent chemotherapy for patients with locally advanced esophageal cancer (LAEC). AIM OF STUDY: The pathologic complete response (pCR) was the primary endpoint to estimate efficacy. METHODS: Twenty-three patients with LAEC received twice-daily XRT during wk 1 and 5 and once-daily XRT during wk 2-4 (59 Gy). Cisplatin (100 mg/m(2)) was given on d 1, while 5-fluorouracil (1000 mg/m(2)) was given by continuous infusion the first and fifth weeks of the XRT. RESULTS: The pCR for the 19 patients undergoing esophagectomy was 16%. The study was closed at the interim analysis having not met the required minimum pCR rate of 20%. Hematologic toxicities consisted of grades III and IV neutropenia observed in 33% and 14% of patients, respectively. Grade III nausea and vomiting was seen in 38% of patients. One grade V pulmonary toxicity occurred. The median survival was 44.6 mo with 65% of patients alive at 2 yr. CONCLUSIONS: The pCR rate in this trial did not meet the predetermined statistical minimum. With the encouraging 2-yr survival, it is not clear that pCR is a reliable surrogate endpoint to discern treatment efficacy.
Authors: Pooja R Rohatgi; Stephen G Swisher; Arlene M Correa; Tsung T Wu; Zhongxing Liao; Ritsuko Komaki; Garrett Walsh; Ara Vaporciyan; Patrick M Lynch; David C Rice; Jack A Roth; Jaffer A Ajani Journal: Cancer Date: 2005-10-01 Impact factor: 6.860
Authors: J F Bosset; M Gignoux; J P Triboulet; E Tiret; G Mantion; D Elias; P Lozach; J C Ollier; J J Pavy; M Mercier; T Sahmoud Journal: N Engl J Med Date: 1997-07-17 Impact factor: 91.245
Authors: Ahmedin Jemal; Taylor Murray; Elizabeth Ward; Alicia Samuels; Ram C Tiwari; Asma Ghafoor; Eric J Feuer; Michael J Thun Journal: CA Cancer J Clin Date: 2005 Jan-Feb Impact factor: 508.702
Authors: M al-Sarraf; K Martz; A Herskovic; L Leichman; J S Brindle; V K Vaitkevicius; J Cooper; R Byhardt; L Davis; B Emami Journal: J Clin Oncol Date: 1997-01 Impact factor: 44.544
Authors: B Jeremic; Y Shibamoto; L Acimovic; Z Matovic; B Milicic; S Milisavljevic; N Nikolic Journal: Int J Radiat Oncol Biol Phys Date: 1998-03-15 Impact factor: 7.038
Authors: Noah Choi; Sung D Park; Thomas Lynch; Cameron Wright; Marek Ancukiewicz; John Wain; Dean Donahue; Douglas Mathisen Journal: Int J Radiat Oncol Biol Phys Date: 2004-09-01 Impact factor: 7.038
Authors: Stephen G Swisher; Jaffer A Ajani; Ritsuko Komaki; Jonathan C Nesbitt; Arlene M Correa; James D Cox; Sandeep Lahoti; Faye Martin; Joe B Putnam; W Roy Smythe; Ara A Vaporciyan; Garrett L Walsh; Jack A Roth Journal: Int J Radiat Oncol Biol Phys Date: 2003-09-01 Impact factor: 7.038
Authors: Arta Monir Monjazeb; Greg Riedlinger; Mebea Aklilu; Kim R Geisinger; Girish Mishra; Scott Isom; Paige Clark; Edward A Levine; A William Blackstock Journal: J Clin Oncol Date: 2010-09-27 Impact factor: 44.544
Authors: A C Lockhart; C E Reed; P A Decker; B F Meyers; M K Ferguson; A R Oeltjen; J B Putnam; S D Cassivi; A J Montero; T E Schefter Journal: Ann Oncol Date: 2014-02-20 Impact factor: 32.976