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Outcome of Single Agent Generic Gemcitabine in Platinum-Resistant Ovarian Cancer, Fallopian Tube Cancer and Primary Peritoneal Adenocarcinoma

  • Suprasert, Prapaporn;Cheewakriangkrai, Chalong;Manopunya, Manatsawee
    • Asian Pacific Journal of Cancer Prevention
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    • v.13 no.2
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    • pp.517-520
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    • 2012
  • Single original gemcitabine is commonly used as salvage treatment in platinum-resistant ovarian cancer, fallopian tube cancer and primary peritoneal adenocarcinoma (PPA) with a satisfactory outcome. However, efficacy data fro this regimen are limited. We therefore conducted a retrospective study to evaluate the outcome of patients who received single-agent generic gemcitabine (GEMITA) after development of clinical platinum resistance. The study period was between May 2008 and December 2010. Gemcitabine was administered intravenously in two different schedules: 1,000 $mg/m^2$ on day 1,8, and 15 every 28 days; and on days 1 and 8 every 21 days with the same dosage. Administration was until disease progression was noted. The response rate was evaluated using the Gynecologic Cancer Intergroup (GCIG) criteria while toxicity was evaluated according to WHO criteria. Sixty-six patients met the inclusion criteria in the study period. Two-thirds of them received gemcitabine as the second and third line regimen. The overall response rate was 12.1%. The median progression free survival and overall survival was 2 and 10 months, respectively. With the total 550 courses of chemotherapy,the patients developed grades 3 and 4 hematologic toxicity as follows: anemia, 1.5%; leukopenia, 13.7%; neutropenia, 27.3%; and thrombocytopenia, 3.0%. In conclusion, single agent generic gemcitabine revealed a modest efficacy in patients with platinum-resistant ovarian cancer, fallopian tube cancer and PPA without serious toxicity.

Sulforaphane Inhibits Growth of Human Breast Cancer Cells and Augments the Therapeutic Index of the Chemotherapeutic Drug, Gemcitabine

  • Hussain, Arif;Mohsin, Javeria;Prabhu, Sathyen Alwin;Begum, Salema;Nusri, Qurrat El-Ain;Harish, Geetganga;Javed, Elham;Khan, Munawwar Ali;Sharma, Chhavi
    • Asian Pacific Journal of Cancer Prevention
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    • v.14 no.10
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    • pp.5855-5860
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    • 2013
  • Phytochemicals are among the natural chemopreventive agents with most potential for delaying, blocking or reversing the initiation and promotional events of carcinogenesis. They therefore offer cancer treatment strategies to reduce cancer related death. One such promising chemopreventive agent which has attracted considerable attention is sulforaphane (SFN), which exhibits anti-cancer, anti-diabetic, and anti-microbial properties. The present study was undertaken to assess effect of SFN alone and in combination with a chemotherapeutic agent, gemcitabine, on the proliferative potential of MCF-7 cells by cell viability assay and authenticated the results by nuclear morphological examination. Further we analyzed the modulation of expression of Bcl-2 and COX-2 on treatment of these cells with SFN by RT-PCR. SFN showed cytotoxic effects on MCF-7 cells in a dose- and time-dependent manner via an apoptotic mode of cell death. In addition, a combinational treatment of SFN and gemcitabine on MCF-7 cells resulted in growth inhibition in a synergistic manner with a combination index (CI)<1. Notably, SFN was found to significantly downregulate the expression of Bcl-2, an anti-apoptotic gene, and COX-2, a gene involved in inflammation, in a time-dependent manner. These results indicate that SFN induces apoptosis and anti-inflammatory effects on MCF-7 cells via downregulation of Bcl-2 and COX-2 respectively. The combination of SFN and gemcitabine may potentiate the efficacy of gemcitabine and minimize the toxicity to normal cells. Taken together, SFN may be a potent anti-cancer agent for breast cancer treatment.

Continuous Transarterial Infusion Chemotherapy with Gemcitabine and 5-Fluorouracil for Advanced Pancreatic Carcinoma

  • Hong, Guo-Bin;Zhou, Jing-Xing;Sun, Hua-Bin;Li, Chun-Yang;Song, Li-Qing
    • Asian Pacific Journal of Cancer Prevention
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    • v.13 no.6
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    • pp.2669-2673
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    • 2012
  • Purpose: Pancreatic carcinoma is one of the most malignant tumors of the alimentary system, with relatively high incidence rates. The purpose of this study was to assess the efficacy and safety of two regimens for advanced pancreatic carcinoma: continuous transarterial infusion versus systemic venous chemotherapy with gemcitabine and 5-fluorouracil. Methods: Of the 48 patients with advanced pancreatic carcinoma receiving chemotherapy with gemcitabine and 5-fluorouracil, 24 received the selective transarterial infusion, and 24 the systemic chemotherapy. For the continuous transarterial infusion group (experimental group), all patients received gemcitabine 1000 mg/$m^2$, given by 30-minute transarterial infusion, on day 1 of a 4-week cycle for 2 cycles, and a dose of 600 mg/$m^2$ 5-fluorouracil was infused on days 1~5 of a 4-week cycle for 2 cycles. For the systemic venous group (control group), gemcitabine and 5-fluorouracil were infused through a peripheral vein, a dose of 1000 mg/$m^2$ gemcitabine being administrated over 30 min on days 1 and 8 of a 4-week cycle for 2 cycles, and a dose of 600 mg/$m^2$ 5-fluorouracil was infused on days 1~5 of a 4-week cycle for 2 cycles. The effectiveness and safety were evaluated after 2 cyclesaccording to WHO criteria. Results:The objective effective rate in transarterial group was 33.3% versus 25% in the systemic group, the difference not being significant (P=0.626). Clinical benefit rates(CBR) in the transarterial and systemic groups were 83.3% and 58.3%, respectively (P=0.014). The means and medians for survival time in transarterial group were higher than those of the systemic group (P < 0.005). at the same time, the adverse effects did not significantly differ between the two groups (P > 0.05). Conclusion: Continuous transarterial infusion chemotherapy with gemcitabine and 5-fluorouracil could improve clinical benefit rate and survival time of patients with advanced pancreatic carcinoma, compared with systemic venous chemotherapy. Since adverse effects were limited in the transarterial group, the regimen of continuous transarterial infusion chemotherapy can be used more extensively in clinical practice. A CT and MRI conventional sequence can be used for efficacy evaluation after chemotherapy in pancreatic carcinoma.

Induction Chemotherapy with Gemcitabine and Cisplatin Followed by Simultaneous Integrated Boost-Intensity Modulated Radiotherapy with Concurrent Gemcitabine for Locally Advanced Unresectable Pancreatic Cancer: Results from a Feasibility Study

  • Woo, Sang Myung;Kim, Min Kyeong;Joo, Jungnam;Yoon, Kyong-Ah;Park, Boram;Park, Sang-Jae;Han, Sung-Sik;Lee, Ju Hee;Hong, Eun Kyung;Kim, Yun-Hee;Moon, Hae;Kong, Sun-Young;Kim, Tae Hyun;Lee, Woo Jin
    • Cancer Research and Treatment
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    • v.49 no.4
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    • pp.1022-1032
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    • 2017
  • Purpose This study assessed the feasibility and compliance of induction chemotherapy with gemcitabine and cisplatin followed by simultaneous integrated boost-intensity modulated radiotherapy (SIB-IMRT) with concurrent gemcitabine in patients with locally advanced unresectable pancreatic cancer. Materials and Methods In this trial, patients received induction chemotherapy consisting of gemcitabine ($1,000mg/m^2$) and cisplatin ($25mg/m^2$) on days 1, 8, and 15 of each treatment cycle. Patients were subsequently treated with gemcitabine ($300mg/m^2/wk$) during SIB-IMRT. The patients received total doses of 55 and 44 Gy in 22 fractions to planning target volume 1 and 2, respectively. As an ancillary study, digital polymerase chain reaction was performed to screen for the seven most common mutations in codons 12 and 13 of the KRAS oncogene of circulating cell free DNA (cfDNA). Results Forty-four patients were enrolled between 2012 and 2015. Of these, 33 (75%) completed the treatment. The most common toxicities during induction chemotherapy were grades 3 and 4 neutropenia (18.2%), grade 3 nausea (6.8%) and vomiting (6.8%). The most common toxicities during SIB-IMRT were grade 3 neutropenia (24.2%) and grade 3 anemia (12.1%). Ten patients (23%) underwent a curative resection after therapy. Median overall survival was significantly longer in patients who underwent curative resection (16.8 months vs. 11 months, p < 0.01). The median cfDNA concentration was significantly lower after treatment (108.5 ng/mL vs. 18.4 ng/mL, p < 0.001). Conclusion Induction chemotherapy with gemcitabine and cisplatin followed by concurrent SIB-IMRT was well tolerated and active.

Gemcitabine Plus Vinorelbine as Second-line Chemotherapy of the Patients of Previously Treated Non-small Cell lung Cancer: Phase II Trial (비소세포 폐암 환자의 이차 치료로서 Gemcitabine과 Vinorelbine 혼합 요법의 효과)

  • Jang, Pil Soon;Kang, Hyun Mo;Lee, Jeong Eun;Kwon, Seon Jung;An, Jin Young;Lee, Yun Sun;Jeong, Sung Soo;Kim, Ju Ock;Kim, Sun Young
    • Tuberculosis and Respiratory Diseases
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    • v.58 no.4
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    • pp.344-351
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    • 2005
  • Background : Both gemcitabine and vinorelbine are effective anticancer drugs with mild toxicity on non-small cell lung cancer, and monotherapy of these drugs are effective as a second-line chemotherapy. The aim of this trial was to assess the response and toxicity of a combination of gemcitabine and vinorelbine in patients of previously treated for non-small cell lung cancer. Materials and Methods : 24 patients, initial stage III A/B,IV and previously treated with platinium and taxane based regimens, were enrolled from June 2000 to March 2004. The regimens consisted of vinorelbine $25mg/m^2$ followed by an infusion of gemcitabine $1000mg/m^2$ on day 1 and day 8 every three weeks. This course was repeated more than twice. Results : Twenty-four patients were analyzed for the response, survival rate, and toxicities. The overall response was 17% with a complete remission rate of 4%. The median time-to progression (TTP) was 3.1 months (95%, CI 1-10months), and the survival time was 8.2 months (95%, CI 1-23 months). The grade 3/4 toxicities encountered were neutropenia (12.5%), anemia (0%), thrombocytopenia (0%). Non-hematological 3/4 toxicities were not observed. Conclusion : A combination of gemcitabine and vinorelbine in patients previously treated for non-small cell lung cancer provides a relatively good response rate, and a low toxicity profile. However, further study will be needed to confirm its effectiveness.

Enhancement of Tumor Radioresponse by Combined Chemotherapy in Murine Mepatocarcinorna (마우스 간암에서 항암제-방사선 복합요법을 이용한 치료 효과 향상)

  • Seong, Jin-Sil;Kim, Sung-Hee;Suh, Chang-Ok
    • Radiation Oncology Journal
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    • v.18 no.4
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    • pp.329-336
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    • 2000
  • Backgrounds : The purpose of this study was to identify drugs that can enhance radioresponse of murine fepatocarcinorna. Methods : CSH/HeJ mice bearing 8 mm tumors of murine fepatocarcinorna, HCa-1, were treated with 25 Gy radiation and one of the following drugs: 5-Fu, 150 mghg; adriamycin, 8 mg/kg; cisplatin, 6 mg/kg; paclitaxel, 40 mg/kg; and gemcitabine, 50 mg/kg. Tumor response to the treatment was determined by tumor growth delay assay and by enhancement factor. Apoptotic level was assessed in tissue sections. Expression of regulating molecules was analyzed by western blotting for p53, Bcl-2, Bax, Bcl-XL, Bcl-XS, and p21$^{WAF1/CIP1}$. Results :Among the drugs tested, only gemcitabine enhanced the antitumor effect of radiation, with enhancement factor of 1.6. Induction of apoptosis by a combination of gemcitabine and radiation was shown as only additive level. In analysis of radiation-induced expression of regulating molecules, the most significant change by combining gemcitabine was activation of p21$^{WAF1/CIP1}$ Conclusion :Gemcitabine is the first drug showing an enhancement of radioresponse in murine hepatocarcinoma, when combined with radiation. The key element of enhancement is thought to be p21$^{WAF1/CIP1}$.

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Expression of ERCC1, RRM1 and LRP in Non-small Cell Lung Cancers and their Influence on Chemotherapeutic Efficacy of Gemcitabine Concomitant with Nedaplatin

  • Qiu, Zhen-Qin;Zhao, Kun
    • Asian Pacific Journal of Cancer Prevention
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    • v.15 no.17
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    • pp.7303-7307
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    • 2014
  • Objective: To explore the clinical efficacy of gemcitabine concomitant with nedaplatin and drug resistance in the treatment of non-small cell lung cancer (NSCLC) and associated molecular predicators. Materials and Methods: A total of 68 patients diagnosed with NSCLC by histology served as the study objects and were randomly divided into an observation group treated with gemcitabine concomitant with nedaplatin and a control group with cisplatin concomitant with gemcitabine, 34 cases for each group. Short-term and long-term efficacies, adverse responses as well as the expression of nucleotide excision repair cross complementing 1 (ERCC1), ribonucleotide reductase subunit M1 (RRM1) and lung resistance-related protein (LRP) in NSCLC tissues in both groups were assessed. Results: The short-term objective response rate (ORR) and disease control rate (DCR) were 35.3% (12/34) and 76.5% (26/34) in the observation group and 38.2% (13/34) and 85.3% (29/34) in the control group, respectively, the differences not being statistically significant. The time to progression (TTP) in both groups were 1~12 months, while the median TTP was 135 d and 144 d, respectively. Though the survival was slightly higher in the control group, there were no significant differences in TTP and survival time. The rates of decreased hemoglobin, vomiting and nausea as well as renal toxicity were evidently lower in the observation group, while other adverse responses demonstrated no significant difference. The positive expression rates of ERCC1, RRM1 and LRP were 47.1% (16/34), 61.8% (21/34) and 64.7% (22/34) in the observation group, respectively. Compared with negative ERCC1 expression, ORR had decreasing trend and the overall survival time (OS) decreased significantly in patients with positive ERCC1 expression, which were markedly decreased by the positive expressions of RRM1 and LRP. Conclusions: Gemcitabine concomitant with nedaplatin has significant effects in the treatment of NSCLC, with an adverse response rate obviously lower than for cisplatin concomitant with gemcitabine, suggesting that wider use in the clinic is warranted. Additionally, the positive expressions of ERCC1, RRM1 and LRP may increase patient drug resistance, so they can be applied as the chemotherapeutic predicators to guide individualized therapy of NSCLC patients.

Phase II Study of Gemcitabine and Vinorelbine as a Combination Chemotherapy for the Second-Line Treatment of Nonsmall Cell Lung Carcinoma (비소세포 폐암 환자의 2차 치료로서 Gemcitabine과 Vinorelbine의 병합 요법의 효과)

  • Lee, EunJoo;Ha, EunSil;Park, SangHoon;Hur, GyuYoung;Jung, KiHwan;Jeong, HyeCheol;Lee, SungYong;Kim, JeHyeong;Lee, SangYeub;Sin, Chol;Shim, JaeJeong;In, KwangHo;Kang, KyungHo;Yoo, SeHwa
    • Tuberculosis and Respiratory Diseases
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    • v.59 no.5
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    • pp.510-516
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    • 2005
  • Backgroud : Lung cancer is the leading cause of cancer deaths in Korea and the number of lung cancer deaths is increasing. The higher response rates, decreased toxicity and improved performance status of the first-line treatments have resulted in an increased number of patients becoming candidates for second-line therapy. Several new antineoplastic agents, including gemcitabine, docetaxel and paclitaxel, have recently demonstrated second-line activity. This phase II study evaluated the efficacy and toxicity of gemcitabine and vinorelbine as combination chemotherapy for Korean patients with NSCLC as a second-line treatment. Methods : Sixty response-evaluable patients were enrolled from December 2000 to July 2003. We conducted a phase II study of a combination gemcitabine and vinorelbine chemotherapy for patients with histologically confirmed NSCLC that was stage IIIB and IV disease at the time of diagnosis, and the disease had progressed onward or the patients had relapsed after first-line platinum-based chemotherapy. They were treated with intravenous gemcitabine $1000mg/m^2$ and intravenous vinorelbine $25mg/m^2$ on days 1 and 8. This chemotherapy regimen was repeated every 3 weeks. Results : A total of 215 cycles of treatment were given and the mean number of cycles was 3.6 cycles. All the patients were evaluable for the toxicity profile. The response rate was 10% according to the WHO criteria. The median progression free survival was 3.8 months and the median survival time was 10.1 months. The 1-year survival rate was 32.9%. Grade III and IV neutropenia were seen in 20 (33.3%) and 7 (11.7%) patients, respectively. Conclusion : The combination of gemcitabine and vinorelbine is active and well tolerated as a second-line therapy for patients with advanced nonsmall cell lung carcinoma.

Concurrent Chemoradiation with Weekly Gemcitabine and Cisplatin for Locally Advanced Cervical Cancer

  • Hashemi, Farnaz Amouzegar;Akbari, Ehsan Hamed;Kalaghchi, Bita;Esmati, Ebrahim
    • Asian Pacific Journal of Cancer Prevention
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    • v.14 no.9
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    • pp.5385-5389
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    • 2013
  • Background: For more than 80 years, the standard treatment of locally advanced cervical cancer was radiotherapy. However, based on several phase III randomized clinical trials in the past decade, concurrent cisplatin-based chemoradiotherapy is the current standard for this disease. Gemcitabine has potent radiosensitizing properties in preclinical and clinical trials, so it can be utilized simultanously with radiation. Materials and Methods: Thirty women with untreated invasive squamous cell carcinoma of the cervix of stage IIB to stage IVA were enrolled in the study in the Radiation Oncology Department of Imam Khomeini Hospital in Tehran from September 2009 to September 2010. Sixty $mg/m^2$ gemcitabine followed by $35mg/m^2$ cisplatin were concurrently administered with radiotherapy to the whole pelvic region on day one of each treatment week for five weeks. One and three months after treatment, patients underwent a complete physical examination and MRI to determine the response to treatment. Results: The mean age of patients was $58.1{\pm}11.8$ (29-78) years. After 3 months of treatment, 73.3%had complete and 26.7% demonstrated partial response to treatment. Grade 3 anemia was seen in 10%, grade 3 thrombocytopenia in 3.3% and grade 3 leukopenia in 10% of the patients. Conclusions: According to the positive results of this study in stage IIB, further phase II and III clinical trials are suggested to evaluate the role of chemoradiation using Gemcitabine for advanced cervical cancers.

Gemcitabine Plus Nedaplatin as Salvage Therapy is a Favorable Option for Patients with Progressive Metastatic Urothelial Carcinoma After Two Lines of Chemotherapy

  • Matsumoto, Kazumasa;Mochizuki, Kohei;Hirayama, Takahiro;Ikeda, Masaomi;Nishi, Morihiro;Tabata, Ken-ichi;Okazaki, Miyoko;Fujita, Tetsuo;Taoka, Yoshinori;Iwamura, Masatsugu
    • Asian Pacific Journal of Cancer Prevention
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    • v.16 no.6
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    • pp.2483-2487
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    • 2015
  • This study was conducted to evaluate the effectiveness of a combination of gemcitabine and nedaplatin therapy among patients with metastatic urothelial carcinoma previously treated with two lines of chemotherapy. Between February 2009 and August 2013, 30 patients were treated with gemcitabine and paclitaxel as a second-line chemotherapy. All had received a first-line chemotherapy consisting of methotrexate, vinblastine, doxorubicin and cisplatin. Ten patients who had measurable histologically proven advanced or metastatic urothelial carcinoma of the urinary bladder and upper urinary tract received gemcitabine $1,000mg/m^2$ on days 1, 8 and 15 and nedaplatin $70mg/m^2$ on day 2 as a third-line chemotherapy. Tumors were assessed by imaging every two cycles. The median number of treatment cycles was 3.5. One patient had partial response and three had stable disease. The disease-control rate was 40%, the median overall survival was 8.8 months and the median progression-free survival was 5.0 months. The median overall survival times for the first-line and second-line therapies were 29.1 and 13.9 months, respectively. Among disease-controlled patients (n=4), median overall survival was 14.2 months. Myelosuppression was the most common toxicity. There were no therapy-related deaths. Gemcitabine and nedaplatin chemotherapy is a favorable third-line chemotherapeutic option for patients with metastatic urothelial carcinoma. Given the safety and benefit profile seen in this study, further prospective trials are warranted given the implications of our results with regard to strategic chemotherapy for patients with advanced or metastatic urothelial carcinoma.