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ABSTRACT: To investigate the feasibility and activity of hyperfractionated radiation therapy (Hfx RT) and concurrent chemotherapy (CT) consisting of low-dose, daily carboplatin and paclitaxel in patients with stage III non-small-cell lung cancer (NSCLC).
Sixty-four patients started their treatment on day 1 with 30 mg/m(2) of paclitaxel administered by 1-hour infusion. Hfx RT began on day 2 using 1.3 Gy bid to a total dose of 67.6 Gy and concurrent low-dose daily CT consisting of 25 mg/m(2) of carboplatin and 10 mg/m(2) of paclitaxel, both given Mondays to Fridays during RT course.
Objective response rate was 83% and included complete response in 27 patients (42%) and partial response in 26 patients (41%). Ten patients (16%) had stable disease, whereas only one patient (2%) had progressive disease. The median survival time was 28 months, and 3- and 5-year survival rates were 37% and 26%, respectively. The median time to local progression was 26 months, and 3- and 5-year local progression-free survival rates were 37% and 33%, respectively. The median time to distant metastasis was 25 months, and 3- and 5- year distant metastasis-free survival rates were 37% and 31%, respectively. Acute high-grade (>/= grade 3) toxicity was hematologic (25%), esophageal (17%), bronchopulmonary (13%), and skin (9%). Late high-grade toxicity was infrequent.
This combined Hfx RT/TC regimen produced results that are among the best ever reported and warrants further study in a prospective randomized fashion.
Journal of Clinical Oncology 02/2005; 23(6):1144-51. · 18.37 Impact Factor
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ABSTRACT: We investigated the influence of interfraction interval (IFI) on treatment outcome in patients with stage III non-small-cell lung cancer (NSCLC) treated with hyperfractionated radiation therapy (Hfx RT) with or without concurrent chemotherapy (CHT). During 3 randomized phase III and 1 phase II study, a total of 536 patients were treated with Hfx RT alone or with concurrent carboplatin/etoposide. Two hundred eighty-five patients were treated with IFI of 4.5-5.0 hours, while 251 patients were treated with IFI of 5.5-6.0 hours. "Shorter" (4.5-5.0 hours) IFI led to better overall survival (OS) (P = 0.0000) and local recurrence-free survival (LRFS) (P = 0.0000). Multivariate analyses showed IFI to be an independent prognosticator of both OS and LRFS. These results were confirmed when we separated all patients (n = 536) into those treated with Hfx RT only (n = 127) and those treated with concurrent RT/CHT (n = 409). Various RT-related high-grade acute toxicity was not different between the 2 IFI, but patients treated with shorter IFI had a significantly higher incidence of hematological toxicity (P = 0.002). None of the late high-grade toxicities were different between the 2 interfraction intervals. Using regression analysis, it was shown that IFI was not a significant predictor of any of acute or late high-grade (> or =3) toxicity. IFI is an important prognosticator of OS and LRFS in patients with stage III NSCLC treated with Hfx RT with or without concurrent carboplatin/etoposide. IFI led to higher incidence only of hematological toxicity, but was not predictive of any acute or late high-grade (> or =3) toxicity. A carefully designed randomized trial seems necessary to give better insight into the issue of optimal IFI in this disease.
American journal of clinical oncology 01/2005; 27(6):616-25. · 2.21 Impact Factor
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ABSTRACT: To retrospectively investigate the difference between conventionally fractionated (CF) and hyperfractionated (Hfx) radiation therapy (RT), with and without either daily cisplatin (CDDP) or carboplatin (CBDCA), in patients with locally advanced squamous cell carcinoma of the head and neck (SCCHN) enrolled onto two consecutive prospective randomized studies.
Treatment consisted of CF RT (70 Gy, group 1), CF RT and either daily CDDP (6 mg/m2) or daily CBDCA (25 mg/m2; group 2), Hfx RT (77 Gy, 1.1 Gy bid; group 3), or Hfx RT and daily CDDP (group 4).
Hfx RT plus CDDP achieved better overall survival (OS) and local recurrence-free survival (LRFS) than any other group. There was an insignificant difference favoring Hfx RT over CF RT, either alone or in combination with CDDP or CBDCA, regarding both OS (P =.058 and P =.051, respectively) and LRFS (P =.088 and P =.091, respectively). No difference was seen between CF RT plus chemotherapy (CHT) and Hfx RT alone regarding either OS (P =.32) or LRFS (P =.48). Regional recurrence-free survival was similar in the four treatment groups. CF RT plus CHT and Hfx RT plus CDDP achieved better distant metastasis-free survival than CF RT and Hfx RT. High-grade toxicity was significantly more frequent in Hfx RT plus CDDP than in any other group, except in the Hfx RT group. Hfx RT led to significantly more acute toxicity and xerostomia than CF RT plus CHT. Hfx RT was more toxic than CF RT, either alone or with concurrent CHT.
Results of this study show that there may be a therapeutic benefit for CF RT plus CHT over Hfx RT plus CDDP in patients with SCCHN, but this cannot be firmly established without a larger and well-planned controlled trial.
Journal of Clinical Oncology 10/2004; 22(17):3540-8. · 18.37 Impact Factor
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ABSTRACT: We investigated the outcome in patients with stage III non-small-cell lung cancer (NSCLC) treated with high-dose hyperfractionated radiation therapy (Hfx RT) and concurrent chemotherapy (CHT) consisting of carboplatin (C) and etoposide (E). During three prospective randomized phase III and one prospective phase II study enrolling a total of 536 patients, 301 patients were treated with high-dose Hfx RT (69.6 Gy) and either low-dose daily CE (50 mg each) (n = 163) or daily CE (30 mg each) accompanied by "weekend" CE (100 mg of each on Saturdays and Sundays) (n = 138). The median survival time for all 301 patients is 22 months and 5-year survival is 24%. Median local recurrence-free survival (LRFS) time is 21 months and 5-year local recurrence-free survival is 32%. The median time to distant metastasis is 25 months, and 5-year distant metastasis-free survival (DMFS) is 35%. Only the type/schedule of CHT administration did not influence overall survival, LRFS, and DMFS. On multivariate analyses using these three endpoints, age stage, interfraction interval, and type/schedule of CHT administration did not predict survival, LRFS, and DMFS, while gender, KPS, and weight loss did. Only high grade hematologic toxicity was more frequent in weekend CHT group. High dose Hfx RT and concurrent low-dose daily CE with or without weekend CE is an active treatment approach in stage III NSCLC that led to high overall survival, LRFS, and DMFS rates.
American journal of clinical oncology 09/2004; 27(4):350-60. · 2.21 Impact Factor
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ABSTRACT: To provide updated outcome data (10 years) of a Phase II study of combined surgery, postoperative radiotherapy, and adjuvant chemotherapy in patients with anaplastic oligodendroglioma and oligoastrocytoma.
In 23 adult patients, surgery, postoperative radiotherapy (60 Gy in 30 daily fractions within 6 weeks), and adjuvant modified chemotherapy (procarbazine 60 mg/m(2) on Days 1-14, lomustine 100 mg/m(2) on Day 1, and vincristine 1.4 mg/m(2) [maximum 2 mg] on Days 1 and 8) were administered every 6 weeks for up to six cycles or until progression occurred.
The median follow-up was 116 months for all patients. The median survival time was 118 months, and the 5-year and 10-year survival rate was 57% and 47%, respectively. The median time to tumor progression was 78 months, with a 5-year and 10-year progression-free survival rate of 52% and 39%, respectively. Gender, age, Karnofsky performance status, location, and histologic type did not influence survival. Patients with tumors <or=4 cm did better than those with tumors >4 cm (p = 0.0470), as did those with total tumor resection compared with those with subtotal tumor resection or biopsy only (p = 0.0024). Gender, Karnofsky performance status, location, and histologic type did not influence progression-free survival, but younger age (p = 0.0389), smaller tumor size (p = 0.0357), and more radical surgery (p = 0.0033) correlated positively with it. Acute high-grade (Grade 3 or worse) chemotherapy-related toxicity was mainly hematologic, with 3 patients (13%) experiencing acute Grade 4 toxicity.
The results of this 10-year update confirmed that the trimodality approach is effective in patients with anaplastic oligodendroglioma and oligoastrocytoma.
International Journal of Radiation OncologyBiologyPhysics 07/2004; 59(2):509-14. · 4.11 Impact Factor
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ABSTRACT: The impact of various clinical pretreatment prognostic factors in patients with malignant glioma treated with a combined modality approach was investigated in 229 patients treated on four consecutive prospective phase II studies. The median survival time for all 229 patients is 14 months, and 2- and 5-year survival rates are 34%, and 9%, respectively. The median time to tumor progression is 14 months, and 2- and 5-year progression-free survival rates are 32%, and 9%, respectively. Females did better than males, while patients 55 years or less did better than those more than 55 years. Patients with Karnofsky performance status (KPS) 80 to 100 did better than those with KPS 50 to 70 as well as did patients having preoperative tumor sizes 4 cm or less when compared to those with larger tumors. Frontal tumor location as well as more extensive surgery favorably influenced survival. Patients harboring anaplastic astrocytoma fared significantly better than those with glioblastoma multiforme. Both univariate and multivariate Cox analyses confirmed independent influence of these prognosticators. When progression-free survival was used as an endpoint, all seven variables remained independent prognosticators. This study showed that sex, age, KPS, tumor size, tumor location, histology, and extent of surgery are independent prognosticators in patients with malignant glioma treated with combined modality approach.
American journal of clinical oncology 05/2004; 27(2):195-204. · 2.21 Impact Factor
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ABSTRACT: To provide a 10-year update of hyperfractionated radiation therapy (Hfx RT) in adults with incompletely resected supratentorial low-grade glioma.
A total of 37 patients were treated with 55 Gy in 50 fractions in 25 treatment days in 5 weeks to tumor plus 2 cm, and additional 17.6 Gy given in 16 fractions in 8 treatment days in 1.5 weeks to tumor plus 1 cm, (1.1 Gy twice daily). Total dose was 72.6 Gy in 66 fractions in 33 treatment days in 6.5 weeks.
After a median follow-up time of 121 months for all patients, the median survival time (MST) for all 37 patients was 145 months, whereas 10-year survival rate was 67%. Median time to tumor progression (MTP) has not yet been attained, but 10-year progression-free survival (PFS) rate was 62%. There was no difference in survival or PFS regarding gender, age, location, site, size, CT enhancement, and histology; whereas lower KPS, higher neurologic status, and lesser extent of surgery had an adverse influence. Infield progression occurred in 15 (88%), whereas in only 2 (12%) patients, tumor progression was described as marginal. Brain necrosis has not been observed so far. Autopsy findings confirmed recurrent glioma and excluded post-RT necrosis in 14 (38%) patients. Of those, 7 (50%) patients had either Grade 3 (n = 4) or Grade 4 (n = 3) glioma.
High-dose HFX RT is effective with mild to moderate toxicity. Further studies are warranted with more patients before testing it against standard fractionation RT in this patient population.
International Journal of Radiation OncologyBiologyPhysics 11/2003; 57(2):465-71. · 4.11 Impact Factor
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ABSTRACT: We investigated the influence of various clinical prognostic factors in patients with glioblastoma multiforme (GBM) treated with a combined modality approach. A total of 175 patients with GBM was treated in four consecutive prospective phase II studies using surgery, hyperfractionated or accelerated hyperfractionated radiotherapy (RT) and either adjuvant or concurrent or pre-irradiation chemotherapy (CHT) between January 1988 and December 1993. The median survival time for all 175 patients was 14 months and 1-3-year survival (OS) rates were 57%, 34% and 24%, respectively. The median time to tumour progression was 12 months, and 1-3-year progression-free survival (PFS) rates were 43%, 11% and 7%, respectively. Survival analysis showed that of all investigated prognostic factors, only gender did not influence survival. Patients </=55 years did better than those >55 years; patients with KPS 80-100 did better than those with KPS 50-70; patients with frontal tumours did better than those with tumours in other locations; patients with tumours up to 4 cm did better than those with larger tumours, as did patients with either subtotal or gross total tumour resection when compared to those undergoing biopsy only. Multivariate analysis showed that gender and tumour location did not independently influence survival. When PFS was used as the endpoint, only gender did not influence PFS, as confirmed by multivariate analysis.
Journal of Cancer Research and Clinical Oncology 09/2003; 129(8):477-84. · 2.56 Impact Factor
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ABSTRACT: We investigated the effect of treatment interruptions due to high-grade (> or =3) toxicity on outcome of patients with early stage (I/II) non-small-cell lung cancer treated with hyperfractionated radiation therapy (Hfx RT). Of 116 patients treated with total tumour doses of 69.6 Gy, 1.2 Gy b.i.d. fractionation, 44 patients refused surgery while 72 patients were medically inoperable due to existing co-morbid states. Patients who were medically inoperable had worse KPS (P=0.0059) and more pronounced weight loss (P=0.0005). Among them, 12 patients experienced high-grade toxicity and 11 of them with either acute (n=6) or "consequential" late (n=5) high-grade toxicity requested interruption in the Hfx RT course (range, 12-25 days; median, 17 days). Superior survival (OS) was observed in patients who refused surgery when compared to those who were medically inoperable (P=0.0041), as well as superior local recurrence-free survival (LRFS) (P=0.011), but not different distant metastasis-free survival (P=0.14). Cause-specific survival (CSS) also favoured patients who refused surgery (P=0.004). Multivariate analysis showed independent influence of the reason for not undergoing surgery on OS (P=0.035), but not on LRFS (P=0.084) or CSS (P=0.068). Patients who refused surgery did not experience high-grade toxicity (0/44), whereas 11 of 72 patients with medical inoperability and co-morbid states experienced high-grade toxicity and had treatment interruptions to manage toxicity (P=0.0064). Patients without treatment interruptions had significantly better OS (P=0.00000), LRFS (P=0.00000) and CSS (P=0.00000) than those with treatment interruptions. When corrected for treatment interruptions, the reason for not undergoing surgery independently influenced OS (P=0.040), but not LRFS (P=0.092) or CSS (P=0.068). In contrast to this, treatment interruption was independent prognosticator of all three endpoints used (P=0.00031, P=0.0075 and P=0.00033, respectively). When 11 patients with treatment interruptions were excluded, the reason for not undergoing surgery still affected OS (P=0.037) and CSS (P=0.039) but not LRFS (P=0.11). Multivariate analyses using OS, CSS and LRFS showed that the reason for not undergoing surgery affected OS (P=0.0436), but neither CSS (P=0.083) nor LRFS (P=0.080).
Lung Cancer 06/2003; 40(3):317-23. · 3.43 Impact Factor
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ABSTRACT: We investigated the influence of potential pre-treatment clinical prognostic factors in stage IV non-small cell lung cancer (NSCLC).
A total of 285 patients were enrolled in two consecutive prospective randomised studies which compared (study 1) carboplatin and prolonged oral etoposide (group 1; n=58) with the same etoposide alone (group 2; n=59), and (study 2) carboplatin and prolonged oral etoposide (group 1; n=84) with the same carboplatin and high-dose intravenous etoposide (group 2; n=84).
The median survival time for all 285 patients was 7 months, while 1- and 2-year survival rates were 29% and 8%, respectively. Age did not impact on outcome ( P=0.21), while female patients did significantly better than male patients ( P<0.0001). Patients with KPS 80-100 did significantly better than those with KPS 50-70 ( P<0.0001), as did patients with less pronounced weight loss ( P<0.0001) and those with only one metastatic site when compared to those having at least two metastatic sites ( P<0.0001). When evaluated regarding the metastatic site, only subcutaneous metastatic site did not influence survival. This was confirmed within univariate analyses, but when multivariate analyses were done gender, KPS, weight loss, number of metastatic sites, presence of liver metastases and presence of brain metastases independently influenced survival, while age and other metastatic locations did not.
In this analysis, gender, KPS, weight loss, number of metastatic sites, presence of liver metastases and presence of brain metastases independently influenced survival in patients with stage IV NSCLC treated with CHT.
Journal of Cancer Research and Clinical Oncology 03/2003; 129(2):114-22. · 2.56 Impact Factor
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ABSTRACT: Many studies have demonstrated an increase of neutrophils in patients with advanced cancer. However, the possible role of increased neutrophils in various neoplasms studied to date varies considerably. The authors examined the changes in white blood cell counts in patients with peritoneal carcinomatosis. Malonildialdehyde and nitric oxide (NO) plasma and ascitic fluid levels, phagocitic activity and the ability of the polymorphonuclear cells (PMNCs) to produce nitric oxide were also measured. An increase in PMNCs and decrease in lymphocytes was found in cancer patients. Compared with healthy controls, cancer PMNCs showed significant enhancement of phagocytosis Similarly, pretreatment of healthy PMNCs with crude supernatants from short-term cultures of the peritoneal cells from ascitic fluid of patients with peritoneal carcinomatosis caused marked stimulation of PMNC phagocytosis. In addition, plasma and ascitic fluid nitric oxide levels in cancer patients were significantly higher than those found in control one. Most importantly, it was found that PMNCs from cancer patients release significantly more nitric oxide than corresponding normal controls. Therefore, considering the fact that neutrophils make up more than 50% of total leukocytes, these cells can play one of the most important roles in tumor biology.
Acta Oncologica 02/2003; 42(8):846-51. · 3.33 Impact Factor
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ABSTRACT: We investigated a risk of developing radiation myelitis during four prospective studies using hyperfractionated radiation therapy (HFX RT) with and without concurrent chemotherapy (CHT) during which a portion of thoracic spinal cord received a dose > or = 50.4 Gy given via 1.2 Gy b.i.d. fractionation. Of 536 patients with Stage III non-small cell lung cancer (NSCLC) which were treated on three prospective randomised Phase III studies and one Phase II study, 336 patients received irradiation dose > or = 50.4 Gy to a portion of their spinal cord and survived >1 year after the beginning of therapy. None of these 336 patients developed thoracic radiation myelitis. Therefore, the influence of potentially contributing factors on the occurrence of radiation myelitis, such as cord length, interfraction interval, or administration of concurrent CHT was not possible to investigate. These results give new insight about the influence of total dose/dose per fraction/interfraction interval with or without concurrent CHT on the thoracic spinal cord toxicity.
Lung Cancer 04/2002; 35(3):287-92. · 3.43 Impact Factor
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ABSTRACT: OBJECTIVE: Nerve transfers in cases of brachial plexus traction injuries with avulsion of spinal nerve roots or irreparable proximal lesions of spinal nerves have been attempted using a variety of donor nerves. The purpose of this study was to analyze the results of nerve transfers to the musculocutaneous and axillary nerves, using collateral branches of the brachial plexus, upper intercostal nerves, or the accessory nerve.
METHODS: This study included 62 patients with brachial plexus traction injuries who were surgically treated using various nerve transfer techniques. The follow-up periods were at least 3 years. Analysis of motor recovery was performed according to the type of donor nerve, the age of the patient, and the timing of surgery.
RESULTS: The rates of recovery for the musculocutaneous and axillary nerves were 50% and 63.2% with intercostal nerve transfers, 65% and 75% with accessory nerve transfers, and 90.4% and 86.9% with nerve transfers of collateral branches, respectively. Despite the obviously better outcomes with the latter technique, a significant difference was found only in comparison with intercostal nerve transfers for the musculocutaneous nerve (P = 0.007). With respect to the quality of recovery, we found a significant difference between the latter type and the other two types of nerve transfers only for the musculocutaneous nerve (P = 0.027 for intercostal nerve transfers and P = 0.05 for accessory nerve transfers). There was no significant difference in results obtained using the thoracodorsal and medial pectoral nerves as donors.
CONCLUSION: Our findings suggest that nerve transfer of collateral branches when possible, such as in cases involving upper brachial plexus palsy, may be the method of choice, yielding better results.
Neurosurgery 12/1999; 46(1):93-103. · 2.79 Impact Factor
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ABSTRACT: Purpose. To evaluate efficacy of short-course radiotherapy (RT) in elderly (60 years) and frail [Karnofsky performance status (KPS) 50–70] patients with glioblastoma multiforme (GBM).Materials and methods. Between January 1987 and June 1993, a total of 47 elderly and frail patients with histological diagnosis of GBM entered into a phase II study. RT alone was administered with tumor dose of 45 Gy in 15 daily fractions in 15 treatment days in 3 weeks to a target volume described as tumor visible on CT scan and a 2-cm margin.Results. Forty-four patients were evaluable for this analysis. There were 15 (34%) CR and 11 (25%) PR, making the overall response rate of 60%. Median duration of response was 9 months (range, 2–36 months). Improvement in pretreatment performance status was observed in 20/44 (45%) patients, 5 of which improved their KPS for 20%. Median survival time is 9 months, and 1–4 year survival rates are 39%, 6.8%, 4.5%, and 0, respectively, while median time to tumor progression is 8 months, and 1–4 year progression-free survival rates are 30%, 4.5%, 4.5%, and 0, respectively. Females did significantly better than males, patients with KPS 60–70 did significantly better than those with KPS 50, patients having tumors 4–5 cm did significantly better than those with tumors 6–8 cm as well as did those with more radical surgery when compared to those with biopsy only. On multivariate analysis, only tumor size and extent of surgery were found to independently influence survival. Acute toxicity was generally assessed as mild. One of the 12 (8%) autopsied patients had RT-induced brain necrosis.Conclusion This shortened RT appears to be an effective tool in palliation of elderly and frail patients with GBM. Further studies with more patients are needed before testing it against more aggressive treatment approaches in this patient population.
Journal of Neuro-Oncology 01/1999; 44(1):85-90. · 3.21 Impact Factor
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ABSTRACT: Purpose: To investigate feasibility, toxicity and antitumor activity of combined surgery, postoperative radiation therapy (RT) and adjuvant chemotherapy (CHT) in adult patients with pure anaplastic oligodendroglioma (PAO) or mixed anaplastic oligoastrocytoma (MAO).Methods: Between January 1988, and June 1993, 23 patients entered into a phase II study. After surgery, post-operative RT was administered with 60Gy in 30 daily fractions in 30 treatment days in 6 weeks. Two weeks after RT, adjuvant modified PCV (mPCV) (Procarbazine, 60mg/m2, days 1–14; CCNU, 100mg/m2, day 1; and vincristine, 1.4mg/m2 (max. 2mg), days 1 and 8) was administered every six weeks up to six cycles or until progression occurred.Results: Median survival time is not attained yet, while 1–5 year survival rates are 100%, 100%, 78%, 61%, and 52%, respectively. Median time to tumor progression is not attained yet, while 1–5 year progression-free survival rates are 100%, 100%, 70%, 52%, and 52%, respectively. On univariate analysis of potential prognostic factors, sex, tumor location (frontal versus other), and histology (pure versus mixed anaplastic oligodendroglioma) were not found to influence survival. Age of 4cm did better than those with tumors >4cm as well as those with total tumor resection when compared to those with subtotal tumor resection or biopsy only. Acute high-grade (3) CHT-related toxicity was mainly hematological with only 3 (13%) patients experiencing acute grade 4 toxicity.Conclusions: Combined treatment modality consisting of surgery, postoperative high-dose RT and mPCV chemotherapy for patients with anaplastic oligodendroglioma was effective with acceptable toxicity. Further studies are needed with more patients and longer follow-up to verify these results in this rare disease.
Journal of Neuro-Oncology 01/1999; 43(2):179-185. · 3.21 Impact Factor
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ABSTRACT: Purpose: To investigate the feasibility and activity of concurrent radiochemotherapy in patients with Stage III nonsmall-cell lung cancer (NSCLC).Materials and Methods: Forty-one patients were treated with hyperfractionated radiation therapy (HfxRT) using 1.2 Gy bid, to a total of 69.6 Gy and concurrent low-dose daily chemotherapy (CHT) consisting of 30 mg of carboplatin (CBDCA) and 30 mg of etoposide (VP-16) given Mondays to Fridays during the RT course. On Saturdays and Sundays during the RT course, CBDCA and VP-16 were both given in a daily dose of 100 mg each.Results: Median survival time was 25 months, and 3- and 5-year survival rates were 34% and 29%, respectively. Median relapse-free survival time was 22 months, and 3- and 5-year relapse-free survival rates were 32%, and 29%, respectively. Median time to local recurrence was 24 months and 3- and 5-year local recurrence-free survival rates were 41% and 38%, respectively. Median time to distant metastasis was 28 months, and 3- and 5- year distant metastasis-free survival rates were 44% and 44%, respectively. Acute high-grade (≥ 3) toxicity was mostly hematological (30%), esophageal (15%), and bronchopulmonary (12%). Late high-grade toxicity was infrequent.Conclusion: This combined radiochemotherapy regimen produced promising results and warrants further studies with more patients before testing it in a prospective randomized fashion.
International Journal of Radiation OncologyBiologyPhysics 12/1998; · 4.11 Impact Factor
