• Title/Summary/Keyword: Randomized Response

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Combined Modality Treatment in Nasopharyngeal Carcinoma (비인강암의 병합요법)

  • Yun, Sang-Mo;Kim, Jae-Cheol;Park, In-Kyu
    • Radiation Oncology Journal
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    • v.19 no.2
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    • pp.100-106
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    • 2001
  • Purpose : We performed a retrospective analysis to compare short term results of induction chemotherapy-radiotherapy versus concurrent chemo-radiotherapy in patients with locally advanced nasopharyngeal carcinoma. Materials and Methods : From Oct. 1989 to May 1998, 62 patients with locally advanced nasopharyngeal carcinoma were treated with induction chemotherapy followed by radiotherapy (induction group) or concurrent chemo-radiotherapy (concurrent group). Induction chemotherapy was done for 50 patients, and concurrent chemotherapy for 12 patients. Age, sex, performance status, and pathologic types were evenly distributed between two groups. Stage distribution showed $32\%$ with IIB, $32\%$ with III, and $38\%$ with IV in induction group, and $50\%,\;33.3\%,\;and\;16.7\%$ in concurrent group, respectively. Chemotherapy regimen was CF (cisplatin and 5-FU) in both groups, and drug delivery method also same. Cisplatin $100\;mg/m^2$ was intravenously infused on day 1, and 5-FU $1,000\;mg/m^2$ on day $2\~6$. This was repeated at 3 weeks interval. At the end of radiotherapy, total cycles of chemotherapy were $1\~3$ (median 2) in both groups. Conventionally fractionated radiotherapy with daily fraction size $1.8\~2.0\;Gy$ and 5 fractions/week was done. Total dose was $69.4\~86\;Gy$(median 73.4 Gy) for induction group, and $69.4\~75.4\;Gy$ (median 70.8 Gy) for concurrent group. Follow-up time was $9\~116$ months (median 40.5 months) for induction group, $14\~29$ months (median 21 months) for concurrent group, respectively. Results : Overall 2 year survival rate (2YSR) for all patients was $78.7\%$. According to treatment modality, 2YSR were $77\%$ for induction group, $87\%$ for concurrent group (p>0.05). 2 year disease-free survival rate were $56\%$ and $81\%\;(p>0.05)$, respectively. Complete response to treatment were $75.5\%$ for induction group and $91.7\%$ for concurrent group, but there was no statistical difference. The incidence of grade $3\~4$ hematologic toxicity during radiotherapy was not differ between two groups, but grade 2 leukopenia was more frequent in concurrent group $(18\%\;vs\;66.7\%)$Grade $3\~4$ mucositis was more frequent in concurrent group $(4.0\%\;vs\;33.3\%)$. Overall incidence of grade $3\~4$ acute toxicity during radiotherapy was more frequent in concurrent group $(6.0\%\;vs\;41.7\%,\;p=0.005)$. Conclusion : Concurrent chemo-radiotherapy showed a trend of improvement in short-term survival and in treatment response when compared with induction chemotherapy-radiotherapy in locally advanced nasopharyngeal carcinoma. More controlled randomized trial are needed.

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The Effect of Adjuvant Chemotherapy in Locally Advanced Head and Neck Squamous Cell Carcinoma after Induction Chemotherapy (국소진행 두경부 상피세포암에서 선행유도약물요법 후 보조약물요법의 효과)

  • Kim Cheol-Woo;Roh Jae-Kyung;Ahn Joong-Bae;Park Joon-Oh;Chung So-Young;Lee Seok;Lee Hey-Ran;Lee Kyung-Hee;Chung Hyun-Cheol;Kim Joo-Hang;Kim Byung-Soo;Suh Chang-Ok;Kim Gwi-Eon
    • Korean Journal of Head & Neck Oncology
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    • v.10 no.1
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    • pp.13-24
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    • 1994
  • Despite optimal local therapy such as surgery and/or radiotherapy, the long term outcome is poor for patients with advanced squamous cell carcinomma of head and neck, due to frequent loco-regional recurrence and distant metastases. We studied to determine whether the combination chemotherapy, especially as an adjuvant chemotherapy, would improve the survival of these patients. Between January, 1986 and December, 1992, 57 patients with previously untreated, locally advanced squamous cell arcinoma of head and neck were assigned to receive 2-3 cycles of induction chemotherapy consisting of 5-fluorouracil(F) and cisplatin(P) every 3 weeks and standard local therapy such as surgery and/or radiotherapy followed by adjuvant chemotherapy with the same FP regimens. Of the 57 enroled patients, 45 patients were evaluable. The obtained results were as following: 1) Among 45 evaluable patients, 18 patients finished all treatment protocol including adjuvant chemotherapy and 27 patients had no adjuvant chemotherapy. The difference of age, sex, performance status, disease stage, and tumor differentiation was not significant statistically between adjuvant chemotherapy group and no-adjuvant chemotherapy group. 2) After induction chemotherapy, 7/45(15.4%), 30/45(67%) achieved complete remission and partial remission respectively with 82.4% overall response rates in entire patients. 3) The 4year progression free survival was 43.3% in adjuvant chemotherapy group and 24.1% in no-adjuvant chemotherapy group(p>0.05). The 4year overall survival was 56.9% and 25.5% respectively(p>0.05). There was no significant different in the patterns of local recurrence and distant metastasis between the two groups. 4) Adverse reactions from combination chemotherapy included nausea, vomiting, mucositis, diarrhea and hematologic bone marrow depression. These were mild and tolerated by patients, and these was no episode of any life threatening toxicities. In conclusion, adjuvant chemotherapy after induction chemotherapy and local therapy did not show statistically significant survival improvement, but there was trend of prolongation of survival when compared to no adjuvant chemotherapy. Thus, large scale phase III randomized controlled studies are strongly recommended.

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Results of Preoperative Concurrent Chemoradiotherapy for Locally Advanced Rectal Cancer (국소진행성 직장암의 수술 전 동시화학방사선요법의 결과)

  • Choi, Sang-Gyu;Kim, Su-Ssan;Bae, Hoon-Sik
    • Radiation Oncology Journal
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    • v.25 no.1
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    • pp.34-42
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    • 2007
  • [ $\underline{Purpose}$ ]: We performed a retrospective non-randomized clinical study of locally advanced rectal cancer, to evaluate the anal sphincter preservation rates, down staging rates and survival rates of preoperative chemoradiotherapy. $\underline{Materials\;and\;Methods}$: From January 2002 to December 2005, patients with pathologically confirmed rectal cancer with clinical stage T2 or higher, or patients with lymph node metastasis were enrolled in this study. A preoperative staging work-up was conducted in 36 patients. All patients were treated with preoperative chemoradiotherapy, and curative resection was performed for 26 patients at Hallym University Sacred Heart Hospital. Radiotherapy treatment planning was conducted with the use of planning CT for all patients. A total dose of $45.0{\sim}52.2\;Gy$ conventionally fractionated three-dimensional radiotherapy was delivered to the whole pelvis. Chemotherapy was given at the first and fifth week of radiation therapy with continuous infusion i.v. 5-FU (Fluorouracil) and LV (Leucovorine). Surgical resection was performed 2 to 4 weeks after the completion of the chemoradiotherapy regimen. $\underline{Results}$: The complete resection rate with negative resection margin was 100% (26/26). However, a pathologically complete response was not seen after curative resection. Surgery was done by LAR (low anterior resection) in 23 patients and APR (abdomino-perineal resection) in 3 patients. The sphincter preservation rate was 88.5% (23/26), down staging of the tumor occurred in 12 patients (46.2%) and down-sizing of the tumor occurred in 19 patients (73%). Local recurrence after surgical resection developed in 1 patient, and distant metastasis developed in 3 patients. The local recurrence free survival rate, distant metastasis free survival rate, and progression free survival rate were 96.7%, 87% and 83.1%, respectively. Treatment related toxicity was minimal except for one grade 3, one grade 4 anemia, one grade 3 leukopenia, and one grade 3 ileus. $\underline{Conclusion}$: Preoperative concurrent chmoradiotherapy for locally advanced rectal cancer seems to have some potential benefits: high sphincter preservation and down staging. Treatment related toxicity was minimal and a high compliance with treatment was seen in this study. Further long-term follow-up with a larger group of patients is required.

Efficiency and Side Effects of Sorafenib Therapy for Advanced Hepatocellular Carcinoma: A Retrospective Study by the Anatolian Society of Medical Oncology

  • Berk, Veli;Kaplan, Mehmet Ali;Tonyali, Onder;Buyukberber, Suleyman;Balakan, Ozan;Ozkan, Metin;Demirci, Umut;Ozturk, Turkan;Bilici, Ahmet;Tastekin, Didem;Ozdemir, Nuriye;Unal, Olcun Umit;Oflazoglu, Utku;Turkmen, Esma;Erdogan, Bulent;Uyeturk, Ummugul;Oksuzoglu, Berna;Cinkir, Havva Yesil;Yasar, Nurgul;Gumus, Mahmut
    • Asian Pacific Journal of Cancer Prevention
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    • v.14 no.12
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    • pp.7367-7369
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    • 2013
  • Background: Inoperable and metastatic hepatocellular carcinoma (HCC) is associated with a poor prognosis and low chemotherapeutic efficiency. Sorafenib is an oral multi-kinase inhibitor exerting its effects via the RAF/MEK/ERK pathway, vascular endothelial growth factor receptor (VEGFR) and platelet derived growth factor receptor beta (PDGFR-${\beta}$) tyrosine kinases. Randomized studies have shown a significant contribution of sorafenib to life expectancy and quality of life of cancer patients. The aim of the present study is to evaluate the efficacy and side effects of sorafenib therapy in Turkey. Materials and Methods: Data for 103 patients (82 males, 21 females) receiving sorafenib therapy in 13 centers from February 2008 to December 2012 were evaluated. Median age was 61 years and median ECOG performance status was 1 (range: 0-2). 60 patients (58%) had hepatitis B, 15 patients (15%) had hepatitis C infection and 12 patients (12%) had a history of alcohol consumption. All of the patients had Child scores meeting the utilization permit of the drug in our country (Child A). Results: A total of 571 cycles of sorafenib therapy were administered with a median of four per patient. Among the evaluable cases, there was partial response in 15 (15%), stable disease in 52 (50%), and progressive disease in 36 (35%). Median progression-free survival was 18 weeks and median overall survival was 48 weeks. The dose was reduced only in 6 patients and discontinued in 2 patients due to grade 3-4 toxicity, 18 patients (17%) suffering hand-foot syndrome, 7 (7%) diarrhea, and 2 (2%) vomiting. Conclusions: This retrospective study demonstrated better efficacy of sorafenib therapy in patients with advanced HCC compared to the literature while progression-free survival and overall survival findings were comparable. The side effect rates indicate that the drug was tolerated well. In conclusion, among the available treatment options, sorafenib is an efficient and tolerable agent in patients with inoperable or metastatic HCC.

Dry Matter Yield and Nutrients Uptake of Sorghum${\times}$Sudangrass Hybrid Grown with Different Rates of Livestock Manure Compost (가축분퇴비 시용 수준에 따른 수수${\times}$수단그라스 교잡종의 건물생산 및 양분 흡수)

  • Lim, Sang-Sun;Lee, Sang-Mo;Lee, Seung-Heon;Choi, Woo-Jung
    • Korean Journal of Soil Science and Fertilizer
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    • v.43 no.4
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    • pp.458-465
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    • 2010
  • To investigate the growth and nutrient uptake response of sorghum${\times}$sudangrass ($S{\times}S$) hybrid to different rate of livestock manure compost, a field experiment was conducted in the experimental grassland of Chonnam National University. Six treatments were laid out in a randomized block design with triplicates; control (no input), synthetic fertilizer (20 g N $m^{-2}$ and 20 g $P_2O_5\;m^{-2}$), compost 1 (3.4 g N $m^{-2}$ and 3.6 g $P_2O_5\;m^{-2}$), compost 2 (6.8 g N $m^{-2}$ and 7.2 g $P_2O_5\;m^{-2}$), compost 4 (13.4 g N $m^{-2}$ and 14.4 g $P_2O_5\;m^{-2}$), and compost 6 (20.2 g N $m^{-2}$ and 21.6 g $P_2O_5\;m^{-2}$). Ninety days after treatment, above-ground parts of the plants were harvested and measured for dry matter yield (DMY) and amounts of nutrients (N and P) uptake. Synthetic fertilizer application achieved the greatest DMY (2.4 kg $m^{-2}$) and nutrient uptake (38.3 g N $m^{-2}$ and 15.3 g $P_2O_5\;m^{-2}$). Increasing compost application rate tended to enhance DMY accumulation and nutrient uptake (P<0.01), but DMYs of compost 4 (1.9 kg $m^{-2}$) and 6 (1.8 kg $m^{-2}$) treatments were not different. Therefore, it was suggested that application compost alone may not achieve DMY of $S{\times}S$ hybrid compatible to synthetic fertilizer application. As nutrient uptake efficiency data showed that availability of compost P could be better than SF, it might be a strategy to apply compost as P source with supplementary N application such as liquid manure, SF or green manure if necessary considering availability of N input and the yield goals.

Immunogenicity, Reactogenicity and Safety of a Combined DTPa-IPV Vaccine Compared with Separate DTPa and IPV Vaccines in Healthy Korean Infants (한국의 건강한 영아를 대상으로 DTPa-IPV 혼합백신을 접종한 경우와 DTPa 백신과 IPV 백신을 각각 투여하였을 경우의 면역원성, 반응원성 및 안전성)

  • Kim, Chang Hwi;Cha, Sung Ho;Shin, Son Moon;Kim, Chun Soo;Choi, Young Youn;Hong, Young Jin;Chey, Myoung Jae;Kim, Kwang Nam;Hur, Jae Kyun;Jo, Dae Sun;Kim, Sung Shin;Lee, Sang Lak;Song, Eun Song;Ramakrishnan, Gunasekaran;Ok, Jin Ju;Van Der Meeren, Olivier;Bock, Hans L.;Kim, Jung Soo
    • Pediatric Infection and Vaccine
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    • v.17 no.2
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    • pp.156-168
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    • 2010
  • Purpose : To compare immunogenicity and reactogenicity of a combined diphtheria-tetanus-acellular pertussis-inactivated poliovirus vaccine (DTPa-IPV, $Infanrix^{TM}$ IPV, GlaxoSmithKline Biologicals) with co-administration of commercially available DTPa and IPV vaccines at separate injection sites (DTPa+IPV). Methods : A total of 458 infants aged 8-12 weeks were randomized to receive three-ose primary vaccination at 2, 4 and 6 months with DTPa-IPV or DTPa+IPV. Blood samples were collected pre and post vaccination for measurement of immune responses. Reactogenicity was assessed following each dose using diary cards. Results : One month post-dose 3, seroprotection rates for anti-diphtheria, anti-tetanus and anti-poliovirus types 1, 2 and 3 were ${\geq}99.5%$ and vaccine response rates to pertussis antigens were at least 98.6% in both DTPa-IPV and DTPa + IPV groups. Non-inferiority between the groups was demonstrated based on pre-defined statistical criteria. Incidences of both local and systemic symptoms were within the same range across both groups with grade 3 symptoms reported following no more than 4.3% of DTPa-IPV doses and 4.5% of DTPa + IPV doses. Two serious adverse events (both pyrexia) after DTPa-IPV administration were considered vaccine-related. Both infants recovered fully. Conclusion : Combined DTPa-IPV vaccine was immunogenic and well tolerated when used as a three-dose primary vaccination course in Korean infants. DTPa-IPV could be incorporated into the Korean vaccination schedule, reducing the number of injections required to complete primary immunization.

Effect of Feeding Aflatoxin $B_1$ and Vitamin $D_3$ on Metatarsus Bone Minerals of Broiler Chicks (Aflatoxin $B_1$과 Vitamin $D_3$ 결여가 Broiler병아리의 중족골 무기물함량에 미치는 영향)

  • 장윤환;여영수
    • Korean Journal of Poultry Science
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    • v.17 no.4
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    • pp.296-302
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    • 1990
  • This study was conducted to investigate the interaction of aflatoxin B$_1$($AFB_1$) and vitamin D$_3$($VD_3$) in broiler chicks. The 336 broiler chicks(Hubbard line) of equally mixed sex were allocated to triplicate 8(2$\times$4 factorial) treatment groups. The 0 or 1ppm of AFB$_1$and 0, 500, 1,000 or 1,500IU/kg of VD$_3$ were supplemented to the basal diet Fourteen broilers of equally mixed sex were allocated to each replica and 24 groups were arranged in a randomized block design After 3 weeks of feeding the metatarsus were collected from the right and left legs of 4 chicks (2 for each sex) per group. The bone ash and minerals were measured. 1. In respect to the fresh weight of metatarsus bone no significant difference was found between 0 and 1ppm $AFB_1$ treatments, however, decreasing trend was recognized when fed increasing level of $VD_3$(P<.01). 2. The ash content in non-fat dry metatarsus bone decreased when fed 1ppm $AFB_1$(P<.01). However, that increased according to the increasing amount of $VD_3$(P<.01). Although there was no interaction between $AFB_1$ and $VD_3$ it was shown that the 1500IU/kg of $VD_3$ was neccessary to cover the decrease in ash content of metatarsus. when fed 1ppm of $AFB_1$. 3. The Ca contents in metatarsus were not influenced by feeding $AFB_1$ but an increasing trend was verified by feeding increasing levels of $VD_3$(P<.05). 4. The P content decreased as $AFB_1$ was fed(P<.01), while no response was found when fed'different levels of $VD_3$ 5. The Cu content decreased when fed $AFB_1$(P<.05). 6. The Na, Mg, K, Zn, Fe and Mn contents were not affected by feeding $AFB_1$ and /or $VD_3$.

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The Effect of Human Albumin Infusion on the Clinical Course of Steroid Sensitive Nephrotic Syndrome (인알부민 투여가 스테로이드 반응성 신증후군의 임상경과에 미치는 영향)

  • Lee Soo Jin;Jeong Ji A;Hwang Soo Ja;Lee Seung Joo
    • Childhood Kidney Diseases
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    • v.4 no.2
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    • pp.102-110
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    • 2000
  • Purpose : Intravenous infusion of albumin has been widely und to relieve severe nephrotic edema in spite of beneficial or harmful effects. The purpose of this study is to examine the harmful effect of albumin on the clinical course of steroid sensitive nephrotic syndrome(SSNS). Method : We prospectively randomized the patients with nephrotic syndrome(biopsy proven or clinically compatible to minimal change nephrotic syndrome) into the albumin group(20$\%$ albumin 1 g/kg) or control group(5$\%$ D/W) between March 1997 and September 1999 at Ewha University Mokdong Hospital. We compared the clinical course of the albumin group(n=13) with the control group(n=13). Results : 1. The duration of steroid therapy until complete remission in the albumin group was significantly longer than the control group($13.7{\pm}6.4\;days\;vs\;7.5{\pm}2.8\;days$)(P<0.05). 2. The remission duration to the first relapse was significantly shorter in the albumin group ($94{\pm}63.5$ days) than the control group($190{\pm}106.4$ days)(P< 0.05). There was no significant difference in the relapse rate within 1 year after complete remission[77$\%$ (10/13) vs 46$\%$ (6/13)](P>0.05) and the relapse frequency per year($1.9{\pm}0.8\;vs\;1.5{\pm}0.5$) between the albumin and control groups. 3. Spot urine protein/creatinine ratio significantly increased in the albumin group at post-albumin 2, 4 days(P<0.05). There was no significant difference in the change of the daily percent weight loss, blood pressure, serum Na, K concentration between the albumin and control groups. Conclusion : Albumin infusion in SSNS delayed the response to steroid and shortened the remission duration to the first relapse. Albumin should be carefully used in nephrotic edema.

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Treatments Results and Prognostic Factors in Locally Advanced Hypopharyngeal Cancer (국소 진행된 하인두암의 치료 결과와 예후 인자 분석)

  • Yoon, Mee-Sun;Ahn, Sung-Ja;Nam, Taek-Keun;Song, Ju-Young;Nah, Byung-Sik;Lim, Sang-Cheol;Lee, Joon-Kyoo;Chung, Woong-Ki
    • Radiation Oncology Journal
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    • v.25 no.3
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    • pp.151-159
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    • 2007
  • Purpose: The purpose of this study is to present the treatment results and to identify possible prognostic indicators in patients with locally advanced hypopharyngeal carcinoma. Materials and Methods: Between October 1985 to December 2000, 90 patients who had locally advanced stage IV hypopharyngeal carcinoma were studied retrospectively. Twelve patients were treated with radiotherapy alone, 65 patients were treated with a combination of chemotherapy and radiotherapy, and 13 patients were treated with surgery and postoperative radiotherapy with or without neoadjuvant chemotherapy. Total radiation dose ranged from 59.0 to 88.2 Gy (median 70 Gy) for radiotherpay alone. Most patients had ciplatin and 5-fluorouracil, and others had cisplatin and pepleomycin or vincristin. Median follow-up period was 15 months. Kaplan-Meier method was used for survival rate and Cox proportional hazard model for multivariate analysis of prognostic factors. Results: Overall 3-and 5-year survival rates were 27% and 17%, respectively. The 2-year locoregional control rates were 33% for radiotherapy alone, 32% for combined chemotherapy and radiotherapy, and 81 % for combined surgery and radiotherapy (p=0.006). The prognostic factors affecting overall survival were T stage, concurrent chemoradiation and treatment response. Overall 3-and 5-year laryngeal preservation rates in combined chemotherapy and radiotherapy were 26% and 22%, respectively. Of these, the 5-year laryngeal preservation rates were 52% for concurrent chemoradiation group (n=11), and 16% for neoadjuvant chemotherapy and radiotherapy (n=54, p=0.012). Conclusion: Surgery and postoperative radiotherapy showed better results than radiotherapy alone or with chemotherapy. Radiotherapy combined with concurrent chemotherapy is an effective modality to achieve organ preservation in locally advanced hypopharyngeal cancer. Further prospective randomized studies will be required.

Efficacy of a Preoperative Concurrent Chemoradiotherapy for the Locally Advanced Unresectable Rectal Cancer (국소진행성 직장암에서 수술 전 방사선 및 항암화학 동시요법의 효과)

  • Cho Jae Ho;Seong Jinsil;Keum Ki Chang;Kim Gwi Eon;Suh Chang Ok;Roh Jae Kyung;Chung Hyun Cheol;Min Jin Sik;Kim Nam Kyu
    • Radiation Oncology Journal
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    • v.18 no.4
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    • pp.293-299
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    • 2000
  • Purpose :We conducted a prospective non-randomized clinical study to evaluate the efficacy and toxic of the preoperative concurrent chemoradiotherapy for locally advanced unresectable rectal cancer. Materials and Methods: Between January 1995 and June 1998, 37 conecutive patients with locally unresectable advanced rectal cancer were entered into the study. With 3- or 4- fields technique, a total of 45 Gy radiation was delivered on whole pelvis, followed by 5.4 Gy boost to the primary tumor in some cases. Chemotherapy was done at the first and fifth week of radiation with bolus i.v. 5-Fluorouracil (FU) 370$\~$450 mg/m$^{2}$, days 1$\~$5, plus Leucovorin 20 mg/m$^{2}$, days 1$\~$5. OF 37 patients, 6 patients did not receive all planned treatment course (refusal in 4, disease progression in 1, metastasis to lung in 1). Surgical resection was undergone 4$\~$6 weeks after preoperative concurrent chemoradiotherapy. Results :Complete resection rate with negative margins was 94$\%$ (29/31). Complete response was seen in 7 patients (23$\%$) clinically and 2 patients (6$\%$) pathologically. Down staging of tumor occured in 21 patients (68$\%$). Treatment related toxicity was minimal except grade III & IV leukopenia in 2 patients, respectively. Conclusion : Preoperative concurrent chemoradiotherapy in locally advanced rectal cancer was effective in inducing down staging and complete resection rate. Treatment related toxicity was minimal. Further follow up is on-going to determine long term survival following this treatment.

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