INT 0123 (Radiation Therapy Oncology Group 94-05) Phase III Trial of Combined-Modality Therapy for Esophageal Cancer: High-Dose Versus Standard-Dose Radiation Therapy

Minsky, Bruce D.; Pajak, Thomas F.; Ginsberg, Robert J.; Pisansky, Thomas M.; Martenson, James A.; Komaki, Ritsuko; Okawara, Gordon; Rosenthal, Seth A.; Kelsen, David P.

doi:10.1200/jco.20.5.1167

Cited by 1,081 publications

(977 citation statements)

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“…In the present study, the clinical complete response rate obtained with cisplatin -irinotecan and radiotherapy regimen was 58.1% (CI 95%: 43.4 -72.8%), in a range similar to that reported with a FU -cisplatin and radiotherapy regimen (Seitz et al, 1990;Poplin et al, 1996;Geh, 2002). The overall survival rate at 2 years of 27.9% (CI 95%: 13.4 -41.3%) in our study was similar to the result of standard treatment of definitive concomitant reported in the RTOG-8501 trial and the recent phase III study with chemo-radiotherapy as definitive treatment (Herskovic et al, 1992;Bedenne et al, 2002;Minsky et al, 2002;Stahl et al, 2005). All results published with cisplatin -irinotecan regimen suggest that its efficacy is similar to that of a standard regimen with FUcisplatin for response rate and overall survival (Geh, 2002).…”

Section: Discussionsupporting

confidence: 89%

“…Moreover, in operable patients with locally advanced oesophageal cancer, the combination of chemotherapy and concurrent radiotherapy has been demonstrated to have an outcome similar to that of surgery after preoperative therapy (Bedenne et al, 2002;Stahl et al, 2005). The standard chemotherapy regimen associates 5 Fluorouracil (FU) with cisplatin (Herskovic et al, 1992;Cooper et al, 1999) and the recommended total dose of concurrent radiation is 50 Gy (Minsky et al, 2002). A number of drugs have been tested in oesophageal cancer Geh, 2002).…”

mentioning

confidence: 99%

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Induction cisplatin–irinotecan followed by concurrent cisplatin–irinotecan and radiotherapy without surgery in oesophageal cancer: multicenter phase II FFCD trial

et al. 2006

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A recent phase I study showed that weekly cisplatin, irinotecan and concurrent radiotherapy can be administered with moderate toxicity in patients with oesophageal cancer. Patients with no prior treatment and oesophageal cancer stage I to III, performance status o3, caloric intake 41500 kcal day À1 were included. Chemotherapy, with cisplatin 30 mg m À2 and irinotecan 60 mg m À2 , was administered at days 1, 8, 22, 29, and concurrently with radiotherapy at days 43, 50, 64 and 71. Radiotherapy was delivered with 50 or 50.4 Gy in 25 fractions/5 weeks. Forty-three patients were included, 10 stage I, 19 stage II and 14 stage III. Mean age was 59.2 years (range 44 -79). A total of 30 out of 43 (69.8%) patients underwent all planned treatment. During induction chemotherapy, 14 severe toxicities of grade 3 or 4 in 10 patients (23.3%) were reported with 57.1% due to haematoxicity. During chemoradiotherapy, 31 severe toxicities of grade 3 or 4 with 64.5% due to haematotoxicity were reported in 18 patients. One toxic death occurred (diarrhoea grade 4). The complete clinical response rate was 58.1% (95% CI: 43.4 -72.8%). Overall survival rate at 1 and 2 years was 62.8%, (95% CI, 58.3 -77.3%) and 27.9% (95% CI, 13.4 -41.3%), respectively. In conclusion, cisplatin -irinotecan -radiotherapy is an active and well-tolerated regimen feasible in out-patients.

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Section: Discussionsupporting

confidence: 89%

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confidence: 99%

Induction cisplatin–irinotecan followed by concurrent cisplatin–irinotecan and radiotherapy without surgery in oesophageal cancer: multicenter phase II FFCD trial

et al. 2006

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“…Therefore, locoregional disease was a component of treatment failure in 84% of cases, whereas metastatic disease was a component in 22%. The overall local failure rate of 42% is similar to other chemoradiation studies (Minsky et al, 2002), but possibly higher than that seen after surgery (Kelsen et al, 1998;Dresner et al, 2000).…”

Section: Discussionsupporting

confidence: 84%

“…Changing body contours and tissue densities together with the close proximity of important normal tissue structures make tumours of the oesophagus a challenging disease in which to deliver a homogenous dose of radiation, and therefore a prime tumour site in which to test innovative technologies such as intensity-modulated radiotherapy (IMRT). There is evidence for a radiation dose effect in this disease (Geh et al, 2000), though attempts to increase the dose have not yet led to an improved outcome (Minsky et al, 2002).…”

Section: Discussionmentioning

confidence: 99%

Definitive chemoradiation in patients with inoperable oesophageal carcinoma

et al. 2004

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We performed a retrospective study of 90 consecutive cases with inoperable carcinoma of the oesophagus treated with definitive chemoradiation at a single cancer centre between 1995 and 2002. For the last 4 years, 73 patients have received therapy according to an agreed protocol. This outpatient-based regimen involves four cycles of chemotherapy, cycles 3 and 4 given concurrently with 50 Gy external beam radiotherapy (XRT) delivered in 25 fractions over 5 weeks. Cisplatin 60 mg m À2 day À1 is given every 3 weeks together with continuous infusional 5-fluorouracil 300 mg m À2 day À1 , reduced to 225 mg m À2 day À1 during the XRT. In all, 45 (50%) patients suffered one or more WHO grade 3/4 toxicity, grade 3 in 93% cases. Patients received more than 90% of the planned chemoradiation schedule. The median overall survival was 26 (15, 496) months, 51% (41, 64) and 26% (13, 52) surviving 2 and 5 years, respectively. Advanced stage, particularly T4 disease, was associated with a worse prognosis. Patients considered not suitable for surgery for reasons other than their disease, mainly co-morbidity, had a significantly better outcome, median survival 40 (26, 496) months, 2-and 5-year survivals 67% (54, 84) and 32% (13, 79), respectively (Po0.001). This schedule is a feasible, tolerable and effective treatment for patients with oesophageal cancer considered unsuitable for surgery.

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“…Recent evidence in oesophageal cancer suggests that increasing the radiotherapy component of CRT may carry significant morbidity without benefit (Minsky et al, 2002). Consequently, in oesophageal cancer the recommended radiation dose from this series remains at 50.4 Gy.…”

Section: Discussionmentioning

confidence: 95%

Concurrent chemoradiotherapy for squamous cell carcinoma of the anus using a shrinking field radiotherapy technique without a boost

Melcher

Sebag‐Montefiore

2003

Br J Cancer

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Chemoradiotherapy (CRT) is now widely accepted as the primary treatment modality for squamous cell cancer of the anus. While randomised trials have clearly shown CRT to be more effective than radiotherapy alone, there remains uncertainty over the optimal integration of chemotherapy and radiation. We describe a series of 50 patients treated by a site specialist gastrointestinal nonsurgical oncologist with CRT at a single UK centre. Chemotherapy comprised mitomycin C (MMC) (day 1) and 5-fluorouracil (5-FU) (days 1 -4, and 29 -32), concurrent with 50 Gy in 25 fractions radiation, using a two-phase shrinking field technique. A radiation boost was not planned. At a median follow-up of 48 months, 11 (22%) of the patients have failed locally, of which three have been surgically salvaged. Nine (18%) have died of anal cancer. These results are comparable with those from large randomised studies, and suggest that a two-phase shrinking field radiotherapy technique with no boost, concurrent with MMC/5-FU chemotherapy, is an effective regimen for this disease. The CRT regimen described here provides the basis for the 'control arm' of the current UK-randomised CRT trial in anal cancer (ACT2).

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INT 0123 (Radiation Therapy Oncology Group 94-05) Phase III Trial of Combined-Modality Therapy for Esophageal Cancer: High-Dose Versus Standard-Dose Radiation Therapy

Cited by 1,081 publications

References 10 publications

Induction cisplatin–irinotecan followed by concurrent cisplatin–irinotecan and radiotherapy without surgery in oesophageal cancer: multicenter phase II FFCD trial

Induction cisplatin–irinotecan followed by concurrent cisplatin–irinotecan and radiotherapy without surgery in oesophageal cancer: multicenter phase II FFCD trial

Definitive chemoradiation in patients with inoperable oesophageal carcinoma

Concurrent chemoradiotherapy for squamous cell carcinoma of the anus using a shrinking field radiotherapy technique without a boost

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