1.Efficacy and safety of neoadjuvant chemotherapy with modified FOLFOX7 regimen on the treatment of advanced gastric cancer.
Jun ZHANG ; Ren-Xiong CHEN ; Jing ZHANG ; Jun CAI ; Hua MENG ; Guo-Cong WU ; Zhong-Tao ZHANG ; Yu WANG ; Kang-Li WANG
Chinese Medical Journal 2012;125(12):2144-2150
BACKGROUNDGastric cancer is one of the most common types of malignant tumors in China and East Asia and has the highest mortality rate of the malignant gastrointestinal tumors. Neoadjuvant chemotherapy is a systemic or local chemotherapy that is given prior to the local treatment of malignant tumors. Neoadjuvant therapy is currently showing some positive prospects; however, its clinical effects remain controversial. In this study, we used the modified FOLFOX7 (mFOLFOX7) regimen as a neoadjuvant chemotherapy regimen. Perioperative clinical and pathological efficacy, toxicity, effects of surgery, postoperative observation, and prognosis were studied to investigate its clinical efficacy and safety.
METHODSEighty patients with advanced gastric cancer were treated in our surgery department from 2005 to 2009; 38 of these patients received mFOLFOX7 neoadjuvant chemotherapy, the other 42 patients assigned to the control group. The perioperative effects of mFOLFOX7 chemotherapy, including clinical effects and toxicity, were observed in each patient.
RESULTSAfter mFOLFOX7 chemotherapy, clinical and pathologic stages decreased in 21.1% and 36.8% of the patients, respectively, but the results were not statistically significant (P = 0.129). The clinical response rate was 50% (19/38). Toxicity was mild; most adverse events were grade I or II and involved no severe infections or deaths. Compared with the control group, the radical resection rate increased (92.1% vs. 85.7%; P = 0.437); surgical effects were completed without an increased incidence of perioperative complications. The 1-, 2-, and 3-year survival rates were 78.70%, 57.40%, and 51.66%, respectively, in the neoadjuvant chemotherapy group and 78.57%, 56.87%, and 43.16%, respectively, in the control group.
CONCLUSIONSThe mFOLFOX7 regimen was very effective and well-tolerated as a neoadjuvant chemotherapy for advanced gastric cancer. However, the 1-, 2-, and 3-year survival rates in the mFOLFOX7 group were not significantly different from the control group.
Adult ; Antineoplastic Combined Chemotherapy Protocols ; adverse effects ; therapeutic use ; Female ; Fluorouracil ; adverse effects ; therapeutic use ; Humans ; Leucovorin ; adverse effects ; therapeutic use ; Male ; Middle Aged ; Neoadjuvant Therapy ; adverse effects ; methods ; Organoplatinum Compounds ; adverse effects ; therapeutic use ; Stomach Neoplasms ; drug therapy ; surgery
2.Report of two cases of hepatitis B virus reactivation in primary liver carcinoma patients treated with the FOLFOX chemotherapy regimen.
Feng WANG ; Shukui QIN ; Haiqing HUA ; Xiufeng LIU ; Wenshu QU ; Ping LI
Chinese Journal of Hepatology 2014;22(3):236-238
Adult
;
Antineoplastic Combined Chemotherapy Protocols
;
adverse effects
;
Fluorouracil
;
adverse effects
;
Hepatitis B virus
;
drug effects
;
physiology
;
Humans
;
Leucovorin
;
adverse effects
;
Liver Neoplasms
;
drug therapy
;
pathology
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Male
;
Middle Aged
;
Neoplasm Staging
;
Organoplatinum Compounds
;
adverse effects
;
Virus Activation
;
drug effects
3.Interstitial Lung Disease Associated with Combination Chemotherapy of Oxaliplatin, 5-Fluorouracil, and Leucovorin.
Sul PARK ; Jae Jin JUNG ; Goeng Bae KIM ; Hyung Sik YOON ; Sang Hun KO ; Jae Ee KO ; Yeun Seun LEE
The Korean Journal of Gastroenterology 2010;55(5):340-343
Oxaliplatin with 5-fluorouracil plus leucovorin (FOLFOX) has become the standard treatment in patients with colorectal cancer. Among known toxicities induced by oxaliplatin, hematological, gastrointestinal and neurological toxicities are common. However, acute pulmonary toxicity associated with oxaliplatin is unusual. One case of interstitial lung disease associated with the FOLFOX protocol is reported here.
Aged
;
Antineoplastic Agents/*adverse effects/therapeutic use
;
Antineoplastic Combined Chemotherapy Protocols
;
Colorectal Neoplasms/drug therapy
;
Fluorouracil/*adverse effects/therapeutic use
;
Humans
;
Leucovorin/*adverse effects/therapeutic use
;
Lung Diseases, Interstitial/chemically induced/*etiology/radiography
;
Male
;
Organoplatinum Compounds/*adverse effects/therapeutic use
4.Interstitial Lung Disease Associated with Combination Chemotherapy of Oxaliplatin, 5-Fluorouracil, and Leucovorin.
Sul PARK ; Jae Jin JUNG ; Goeng Bae KIM ; Hyung Sik YOON ; Sang Hun KO ; Jae Ee KO ; Yeun Seun LEE
The Korean Journal of Gastroenterology 2010;55(5):340-343
Oxaliplatin with 5-fluorouracil plus leucovorin (FOLFOX) has become the standard treatment in patients with colorectal cancer. Among known toxicities induced by oxaliplatin, hematological, gastrointestinal and neurological toxicities are common. However, acute pulmonary toxicity associated with oxaliplatin is unusual. One case of interstitial lung disease associated with the FOLFOX protocol is reported here.
Aged
;
Antineoplastic Agents/*adverse effects/therapeutic use
;
Antineoplastic Combined Chemotherapy Protocols
;
Colorectal Neoplasms/drug therapy
;
Fluorouracil/*adverse effects/therapeutic use
;
Humans
;
Leucovorin/*adverse effects/therapeutic use
;
Lung Diseases, Interstitial/chemically induced/*etiology/radiography
;
Male
;
Organoplatinum Compounds/*adverse effects/therapeutic use
5.Efficacy evaluation of heat-sensitive moxibustion for chemotherapy symptoms of large intestine cancer.
Zhiping LI ; Zhi ZHENG ; Lijun WANG ; Weiyun XIAO ; Jiquan ZENG ; Jing HAO ; Rixin CHEN ; Dingyi XIE
Chinese Acupuncture & Moxibustion 2015;35(10):1010-1013
OBJECTIVETo analyze and evaluate the clinical efficacy of heat-sensitive moxibustion for symptoms of large intestine cancer.
METHODSSixty patients with large intestine cancer were randomly divided into an observation group and a control group, 30 cases in each one. FOLFOX chemotherapy regimen was used in the two groups,and heat-sensitive moxibustion was added in the observation group. The acupoints were Zusanli(ST 36), Sanyinjiao (SP 6) Xuehai (SP 10) and Geshu (BL 17), etc. The treatment was applied once a day,five-day treatment as one course. Four courses were required. The reaction rates of uncomfortable symptoms by the Chinese version of the M. D. Anderson symptom inventory (MDASI-C) scale and clinical effects were analyzed and evaluated in the two groups.
RESULTSAfter treatment, the MDASI-C reaction rate of uncomfortable symptoms in the observation group was 50.4% which was lower than 53.3% in the control group (P < 0.05). The total effective rate of symptom improvement in the observation group was 83.3% (25/30), which was higher than 60.0% (18/30) in the control group (P < 0.05).
CONCLUSIONHeat-sensitive moxibustion can improve symptoms of chemotherapy for large intestine cancer.
Aged ; Antineoplastic Agents ; adverse effects ; therapeutic use ; Antineoplastic Combined Chemotherapy Protocols ; adverse effects ; therapeutic use ; Colorectal Neoplasms ; drug therapy ; Drug-Related Side Effects and Adverse Reactions ; etiology ; therapy ; Female ; Fluorouracil ; adverse effects ; therapeutic use ; Humans ; Intestine, Large ; drug effects ; Leucovorin ; adverse effects ; therapeutic use ; Male ; Middle Aged ; Moxibustion ; instrumentation ; Organoplatinum Compounds ; adverse effects ; therapeutic use ; Treatment Outcome
6.Yiqi zhuyu decoction combined with FOLFOX-4 as first-line therapy in metastatic colorectal cancer.
Bo CAO ; Shao-tang LI ; Zhi LI ; Wen-ling DENG
Chinese journal of integrative medicine 2011;17(8):593-599
OBJECTIVETo evaluate the efficacy and safety of yiqi zhuyu decoction (YZD) combined with oxaliplatin plus 5-flurouracil/leucovorin (FOLFOX-4) in the patients with metastatic colorectal cancer (MCRC).
METHODSA total of 120 patients with MCRC were randomly divided into the experimental group (FOLFOX-4 plus YZD, 60 cases) and the control group (FOLFOX-4 plus placebo, 60 cases), according to the sequence of hospitalization from January 2005 to December 2007. The treatment was supposed to be continued until disease progression (PD) or for 48 weeks (i.e., up to 24 cycles of FOLFOX-4). Response rate (RR), progression-free survival (PFS), overall survival (OS) and adverse events (AEs) were observed.
RESULTSRR was 41.5% in the experimental group and 34.0% in the control group [odds ratio (OR): 1.18, 95% CI: 0.77 to 1.82, P=0.432]. Median PFS were 9.0 months and 8.0 months, respectively [hazard ratio (HR): 0.78, 95% CI: 0.53 to 1.15, P=0.215]. Median OS were 21.0 months and 18.0 months (HR: 0.65, 95% CI: 0.43 to 0.99, P=0.043) and grade 3/4 AEs were 56.6% and 76.7% (OR: 0.61, 95% CI: 0.18 to 0.87, P=0.020), respectively.
CONCLUSIONSYZD combined with FOLFOX-4 chemotherapy significantly improved OS in this first-line trial in the patients with MCRC and significantly decreased grade 3/4 AEs. However, RR was not improved, and PFS did not reach statistical significance by the addition of YZD. The treatment of YZD combined with FOLFOX-4 may be necessary in order to optimize efficacy and safety.
Antineoplastic Agents ; adverse effects ; therapeutic use ; Antineoplastic Combined Chemotherapy Protocols ; adverse effects ; therapeutic use ; Colorectal Neoplasms ; drug therapy ; pathology ; Disease-Free Survival ; Drugs, Chinese Herbal ; adverse effects ; therapeutic use ; Female ; Fluorouracil ; adverse effects ; therapeutic use ; Humans ; Intention to Treat Analysis ; Leucovorin ; adverse effects ; therapeutic use ; Male ; Middle Aged ; Neoplasm Metastasis ; Organoplatinum Compounds ; adverse effects ; therapeutic use ; Patient Dropouts ; Treatment Outcome
7.A Phase II Study of Cetuximab (Erbitux(R)) plus FOLFIRI for Irinotecan and Oxaliplatin-refractory Metastatic Colorectal Cancer.
Dong Hoe KOO ; Jae Lyun LEE ; Tae Won KIM ; Heung Moon CHANG ; Min Hee RYU ; Sung Sook LEE ; Min Kyoung KIM ; Sun Jin SYM ; Jung Shin LEE ; Yoon Koo KANG
Journal of Korean Medical Science 2007;22(Suppl):S98-S103
We have evaluated the efficacy and safety of cetuximab plus FOLFIRI for irinotecan and oxaliplatin-refractory colorectal cancers. From September 2004 to February 2006, 31 patients with metastatic colorectal cancer were treated with cetuximab (400 mg/m2 intravenously [IV] over 2 hr on day 1 followed by weekly 1-hr infusions of 250 mg/m2) plus bi-weekly FOLFIRI (irinotecan 150 mg/m2 IV over 90 min, and leucovorin 100 mg/m2 IV over 2 hr, followed by 5-FU 400 mg/m2 IV bolus on day 1, and followed by 5-FU 2,400 mg/m2 by continuous IV over 46 hrs). Patients received a median of four cycles (range: 1-23). Eight (25.8%) patients had confirmed partial responses and 10 (32.2%) had stable disease. After a median follow-up of 13.2 months for surviving patients, the median time to progression was 2.9 months, the median duration of response was 5.4 months, and the median overall survival was 10.9 months. Skin toxicity was observed in 25 patients (80.4%) including grade 3 in 6 patients (19.4%). Other common non-hematologic toxicities of all grades were mucositis (32.3%), asthenia (22.6%), diarrhea (12.9%), and paronychial cracking (12.9%). The combination of cetuximab with FOLFIRI was effective and tolerable in colorectal cancer patients heavily pretreated with a number of chemotherapy regimens.
Adult
;
Aged
;
Antibodies, Monoclonal/*administration & dosage/adverse effects
;
Antineoplastic Agents/*administration & dosage/adverse effects
;
Antineoplastic Combined Chemotherapy Protocols/*administration & dosage/adverse
;
Camptothecin/administration & dosage/adverse effects/analogs & derivatives
;
Colorectal Neoplasms/*drug therapy/secondary
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Drug Resistance, Neoplasm
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Female
;
Fluorouracil/administration & dosage/adverse effects
;
Humans
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Leucovorin/administration & dosage/adverse effects
;
Male
;
Middle Aged
;
Organoplatinum Compounds/pharmacology
;
Prognosis
;
Receptor, Epidermal Growth Factor/antagonists & inhibitors
;
Safety
8.Phase II Study of Low-dose Paclitaxel and Cisplatin as a Second-line Therapy after 5-Fluorouracil/Platinum Chemotherapy in Gastric Cancer.
Keun Wook LEE ; Jee Hyun KIM ; Tak YUN ; Eun Kee SONG ; Im Il NA ; Hyunchoon SHIN ; So Yeon OH ; In Sil CHOI ; Do Youn OH ; Dong Wan KIM ; Seock Ah IM ; Tae You KIM ; Jong Seok LEE ; Dae Seog HEO ; Yung Jue BANG ; Noe Kyeong KIM
Journal of Korean Medical Science 2007;22(Suppl):S115-S121
This study was performed to evaluate the efficacy and toxicity of low-dose paclitaxel/cisplatin chemotherapy in patients with metastatic or recurrent gastric cancer that had failed 5-fluorouracil/platinum-based chemotherapy. Thirty-two patients with documented progression on or within 6 months after discontinuing 5-fluorouracil/platinum-based chemotherapy were enrolled. As a second-line treatment, paclitaxel (145 mg/m2) and cisplatin (60 mg/m2) was administered on day 1 every 3 weeks. Among 32 patients enrolled, 8 (25%) responded partially to paclitaxel/cisplatin, 8 (25%) had stable disease, and 14 (44%) had progressive disease. Two patients (6%) were not evaluable. The median time to progression (TTP) and overall survival for all patients were 2.9 months and 9.1 months, respectively. The most common hematologic toxicity was anemia (47%). Grade 3 neutropenia developed in three patients (9%), but no other grade 3/4 hematologic toxicity occurred. The most common non-hematologic toxicities were emesis (31%) and peripheral neuropathy (38%). Three cases (9%) of grade 3/4 emesis and 2 cases (6%) of grade 3 peripheral neuropathy developed. In conclusion, low-dose paclitaxel and cisplatin chemotherapy showed moderate activity with favorable toxicity profiles. However, relatively short TTP of this regimen warrants the development of more effective paclitaxel-based regimens other than combination with cisplatin in these patients as second-line therapies.
Adenocarcinoma/*drug therapy
;
Adult
;
Aged
;
Antineoplastic Combined Chemotherapy Protocols/*administration & dosage/adverse
;
Cisplatin/administration & dosage/adverse effects
;
Female
;
Fluorouracil/administration & dosage/adverse effects
;
Humans
;
Leucovorin/administration & dosage/adverse effects
;
Male
;
Middle Aged
;
Organoplatinum Compounds/administration & dosage/adverse effects
;
Paclitaxel/administration & dosage/adverse effects
;
Stomach Neoplasms/*drug therapy/mortality
;
Survival Rate
;
Treatment Failure
9.Prospective Randomized Trials Comparing Intravenous 5-Fluorouracil and Oral Doxifluridine as a Postoperative Adjuvant Treatment for Advanced Rectal Cancer.
Nam Kyu KIM ; Kang Young LEE ; Jea Kun PARK ; Seong Hyeun YUN ; Jae Kyung ROH ; Jin Sik MIN
Journal of the Korean Surgical Society 2001;60(2):195-199
PURPOSE: Intravenous 5-Fluorouracil (5-FU) and oral doxifluridine were compared with respect to therapeutic efficacy, drug toxicity, and quality of life to clarify the efficiency of oral doxifluridine. METHODS: One hundred sixty-six (166) patients who underwent a curative resection for TNM stage II and III rectal cancer between Oct. 1997 and Feb. 1999 were randomized to receive intravenous 5-FU (450 mg/m2/day) or oral doxifluridine (700 mg/m2/day) in combination with leucovorin (20 mg/m2/day). 5-FU was infused intravenously 5 consecutive days per month for a total of 12 cycles (IV arm, N=74) in one group, and doxifluridine was given orally daily for 3 weeks with a rest of 1 week for a total of 12 cycles (Oral arm, N=92). Drug toxicity and quality of life were observed. Quality of life was scored according to twenty-two daily activity items (good,>71, fair,53< or =and<70, poor,< or =52). RESULTS: There was no significant difference in the mean age, sex, TNM stage distribution, or type of operation between the two groups (>0.05). Mean number of chemotherapy cycles was 6.5+/-3.7 (IV arm) vs 7.2+/-4.3 (Oral arm). The recurrence rate was 9/74 (12.1%) in IV arm and 6/92 (6.5%) in oral arm (P=0.937). Local recurrence was 2/74 (stage III; 2.7%) in IV arm and 1/92 (stage II; 1.1%) in oral arm. Systemic recurrence was 7/74 (Stage III; 9.4%) in IV arm and 5/92 (Stage III; 5.4%) in oral arm. Toxicity pro-files are as follows: Leukopenia (30/74, 17/92) and alopecia (21/74, 13/92) were more common in IV arm than in oral arm, and the difference was statistically significant. Diarrhea was more common in oral arm. The quality of life score was better at 1 month (19.5%, 49%) and at 2 months (47%, 72%) in the oral arm group (<0.05). CONCLUSION: Oral Doxifluridine with leucovorin as a postoperative adjuvant therapy shows a therapeutic efficacy comparable to the intravenous 5-FU regimen and has a high quality of life. The oral regimen also can be safely given with an appropriate toxicity and tolerability.
Alopecia
;
Arm
;
Diarrhea
;
Drug Therapy
;
Drug-Related Side Effects and Adverse Reactions
;
Fluorouracil*
;
Humans
;
Leucovorin
;
Leukopenia
;
Prospective Studies*
;
Quality of Life
;
Rectal Neoplasms*
;
Recurrence
10.Diffuse alveolar damage during chemotherapy with oxaliplatin, 5-fluorouracil and leucovorin.
Kyoung Ju LEE ; Ki Hwan JUNG ; In Keun CHOI ; Je Hyeong KIM ; Jae Hong SEO ; Young Sik KIM ; Chol SHIN
Korean Journal of Medicine 2006;71(1):86-90
The combination chemotherapy of oxaliplatin with 5-fluorouracil and leucovorin (FOLFOX regimen) has been recently proved to be beneficial in advanced colorectal and gastric cancer. Side effects of this regimen include neutropenia, diarrhea, and neurosensory toxicity. However, the case reports about pulmonary toxicities of this regimen are very limited. Herein is the reported case of a patient treated with oxaliplatin, 5-fluorouracil and leucovorin combination chemotherapy in whom diffuse alveolar damage developed and the disease improved after steroid pulse therapy.
Diarrhea
;
Drug Therapy*
;
Drug Therapy, Combination
;
Drug-Related Side Effects and Adverse Reactions
;
Fluorouracil*
;
Humans
;
Leucovorin*
;
Lung Diseases, Interstitial
;
Neutropenia
;
Stomach Neoplasms