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.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
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Leucovorin/*adverse effects/therapeutic use
;
Lung Diseases, Interstitial/chemically induced/*etiology/radiography
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Male
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Organoplatinum Compounds/*adverse effects/therapeutic use
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
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Male
;
Organoplatinum Compounds/*adverse effects/therapeutic use
4.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
5.Median effective effect-site concentration of intravenous anesthetics for loss of consciousness in neoadjuvant chemotherapy patients.
Zi-jing HE ; Yong-hua HU ; Zhi-yi FAN
Chinese Medical Journal 2011;124(4):504-508
BACKGROUNDIn recent years, increasing numbers of patients are accepting neoadjuvant chemotherapy before their operation in order to get a better prognosis. But chemotherapy has many side-effects. We have observed that patients who accepted neoadjuvant chemotherapy are more sensitive to anesthetics. The aim of this study was to determine the median effective dose (EC(50)) of intravenous anesthetics for neoadjuvant chemotherapy patients to lose consciousness during target-controlled infusion.
METHODSTwo hundred and forty breast cancer patients undergoing elective operations were assigned to six groups according to treatment received before their operation and the use of intravenous anesthetics during anesthesia; non-adjuvant chemotherapy + propofol group (group NP, n = 40), Taxol + propofol group (group TP, n = 40), adriamycin + cyclophosphamide + 5-Fu + propofol group (group CP, n = 40), non-adjuvant chemotherapy + etomidate group (group NE, n = 40), taxol + etomidate group (group TE, n = 40), adriamycin + cyclophosphamide + 5-Fu + etomidate group (group CE, n = 40). We set the beginning effect-site concentration (Ce) of propofol as 3.0 µg/ml and etomidate as 0.2 µg/ml. The concentration was increased by steps until the patient was asleep, (OAAS class I-II), then gave fentanyl 3 µg/kg and rocuronium 0.6 mg/kg and intubated three minutes later. The patients' age, height, and weight were recorded. BIS was recorded before induction, at the initial effect-site concentration and at loss of consciousness. The effect-site concentration was recorded when patient lost consciousness.
RESULTSThere were no significant differences between groups in general conditions before treatment; such as BIS of consciousness, age, sex and body mass index. The EC(50) of propofol in the NP, TP and CP groups was 4.11 µg/ml (95%CI: 3.96 - 4.26), 2.94 µg/ml (95%CI: 3.36 - 3.47) and 2.91 µg/ml (95%CI: 3.35 - 3.86), respectively. The EC50 of etomidate in the NE, TE and CE groups was 0.61 µg/ml (95%CI: 0.55 - 0.67), 0.38 µg/ml (95%CI: 0.33 - 0.44), and 0.35 µg/ml (95%CI: 0.34 - 0.36), respectively. There was no significant difference of BIS level before induction or in BIS50 level in any group when patients lost consciousness.
CONCLUSIONSThe EC(50) of intravenous anesthetics to cause loss of consciousness in neoadjuvant chemotherapy groups is lower than in the control group. There was no significant difference of BIS level at which patients lost consciousness.
Adult ; Anesthetics, Intravenous ; therapeutic use ; Breast Neoplasms ; drug therapy ; surgery ; Cyclophosphamide ; therapeutic use ; Doxorubicin ; therapeutic use ; Etomidate ; therapeutic use ; Female ; Fluorouracil ; therapeutic use ; Humans ; Middle Aged ; Neoadjuvant Therapy ; adverse effects ; Paclitaxel ; therapeutic use ; Propofol ; therapeutic use ; Unconsciousness ; chemically induced
6.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
7.Evaluation of two different regimens as neoadjuvant chemotherapy for breast cancer.
Deqi YANG ; Fuzhong TONG ; Yingming CAO ; Peng LIU ; Bo ZHOU ; Hongjun LIU ; Xinmin QIAO ; Jiaqing ZHANG
Chinese Journal of Oncology 2002;24(3):303-305
OBJECTIVETo compare the efficacy and toxicity of two different regimens as neoadjuvant chemotherapy for breast cancer.
METHODSForty-eight patients with stage II, III breast cancer as proved by cytology biopsy, were treated with either 5-Fu, epirubicin, cyclophosphamide (FEC) or epirubicin, paclitaxel (ET) regimens for 2 cycles every 3 - 4 weeks. Clinical responses in the breast and lymph nodes were assessed after 2 cycles of neoadjuvant chemotherapy. Patients in FEC arm received combination of 5-fluorouracil (5-Fu) 500 mg/m(2) by 4-hour continuous infusion on D1 and D8, epirubicin (EPI) 50 mg/m(2) by intravenous injection on D1, and cyclophosphamide (CTX) 500 mg/m(2) by intravenous injection on D1 and D8. Patients assigned to the ET arm received EPI 60 mg/m(2) by intravenous injection on D1, paclitaxel (TAX) 150 mg/m(2) by 3-hour continuous infusion on D2. All patients were treated by operation 2 weeks later and radiotherapy was added to some.
RESULTSFor primary tumor in the breast, the overall response rate (RR) was 50.0% (12/24) in FEC arm and 79.2% (19/24) in ET arm. One patient showed clinical complete response (cCR), 11 partial response (PR), 12 no change (NC) after the FEC therapy, while 1 patient showed CR, 18 PR, 5 NC after ET therapy. There was no pathologic complete response or progressive disease, though a higher proportion of RR was observed in stage II than stage III patients in these two groups. Clinically palpable axillary lymph nodes which had been found in all 48 patients before 2 cycles of treatment, 50.0% (12/24) in the FEC patients and 66.7% (16/24) in the ET patients became in-palpable. The major toxicity, including leukopenia, gastroenteric reactions, were similar in both groups, but alopecia was more severe and arthralgia, myalgia, neurotoxicity and flushing of face were the unique features of the ET regimen.
CONCLUSIONNeoadjuvant chemotherapy with two different regimens were effective to the primary tumor and axillary metastatic lymph nodes of breast cancer, and the side effects were tolerable. Higher efficacy and more side effects are observed in ET than in FEC regimen.
Adult ; Aged ; Antineoplastic Combined Chemotherapy Protocols ; adverse effects ; therapeutic use ; Breast Neoplasms ; drug therapy ; Cyclophosphamide ; adverse effects ; therapeutic use ; Epirubicin ; adverse effects ; therapeutic use ; Female ; Fluorouracil ; adverse effects ; therapeutic use ; Humans ; Middle Aged ; Neoadjuvant Therapy ; Neoplasm Staging ; Paclitaxel ; adverse effects ; therapeutic use ; Taxoids ; Treatment Outcome
8.Randomized controlled clinical trial of kang'ai injection in gastrointestinal cancerchemotherapy patients.
Yin CHEN ; Mei-zuo ZHONG ; Ming LU
China Journal of Chinese Materia Medica 2012;37(19):2990-2992
OBJECTIVETo study the influence of kang'ai injection on quality of life among gastrointestinal cancer chemotherapy patients.
METHODFourty-two gastrointestinal cancer patients were randomly divided into the treatment group (n=22) and the control group (n=20). The treatment group was treated with chemotherapy and kang'ai injection, and the control group was only treated with chemotherapy. Their quality of life, improvement of clinical symptoms and adverse effects were observed.
RESULTThe disease control rates of the treatment group and the control group were 91% and 30% ,while their effective rates of KPS were 59% and 30% respectively. They had one case and six cases with side effects above III degree.
CONCLUSIONKang'ai injection can mitigate syndromes of gastrointestinal cancer chemotherapy patient, improve their quality of life and have an effect of reducing toxic and enhancing efficacy for chemotherapy.
Aged ; Antineoplastic Combined Chemotherapy Protocols ; adverse effects ; therapeutic use ; Case-Control Studies ; Drugs, Chinese Herbal ; administration & dosage ; adverse effects ; therapeutic use ; Female ; Fluorouracil ; adverse effects ; therapeutic use ; Gastrointestinal Neoplasms ; drug therapy ; pathology ; Humans ; Leucovorin ; adverse effects ; therapeutic use ; Male ; Middle Aged ; Neoplasm Staging ; Organoplatinum Compounds ; adverse effects ; therapeutic use ; Treatment Outcome
9.Efficacy and Safety of FOLFIRI after Failure of FOLFOX-4 in Advanced Gastric Cancer.
Hye Jung KWON ; Moo In PARK ; Seun Ja PARK ; Won MOON ; Sung Eun KIM ; Hae Won LEE ; Youn Jung CHOI ; Jae Hyun KIM
The Korean Journal of Gastroenterology 2015;66(1):10-16
BACKGROUND/AIMS: The purpose of this study was to investigate the efficacy and safety of irinotecan based FOLFIRI chemotherapy as a second-line treatment after failure of FOLFOX-4 chemotherapy in patients with advanced gastric cancer. METHODS: Fifty-two patients who were pathologically diagnosed with unresectable gastric cancer and received FOLFIRI chemotherapy after failure of FOLFOX-4 chemotherapy between September 2005 and February 2012 were enrolled in this study. Data were collected by retrospectively reviewing the medical records. The response to chemotherapy was assessed every 3 cycles by World Health Organization criteria and long term survival was analyzed. The toxicities were evaluated for every course of chemotherapy according to National Cancer Institution (NCI) toxicity criteria version 3.0. RESULTS: Median age of the patients was 57 years. Median overall survival (OS) and time to progression (TTP) were 7.8 and 5 months, respectively. The number of patients showing complete remission, partial remission, stable disease, and progressive disease were 0 (0.0%), 9 (17.3%), 30 (57.7%), and 13 (25.0%), respectively. The overall response rate was 17.3%. During a total of 345 cycles, anemia worse than NCI toxicity grade 3 occurred in 2.9%, leukopenia in 20.3%, neutropenia in 12.2%, and thrombocytopenia in 1.5%. Patients with less organ involvement by metastasis, less than 34 U/mL of CA 19-9 and good responsiveness to third cycle of second line chemotherapy were associated with longer OS and TTP. CONCLUSIONS: FOLFIRI chemotherapy has a modest efficacy with acceptable toxicities in patients with advanced gastric cancer as a second-line treatment. Further well-controlled studies are needed to elucidate the efficacy of FOLFIRI chemotherapy as second-line treatment in patients with advanced stomach cancer.
Adult
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Aged
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Anemia/etiology
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Antineoplastic Combined Chemotherapy Protocols/adverse effects/*therapeutic use
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Camptothecin/adverse effects/*analogs & derivatives/therapeutic use
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Disease Progression
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Female
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Fluorouracil/adverse effects/therapeutic use
;
Humans
;
Kaplan-Meier Estimate
;
Leucovorin/adverse effects/therapeutic use
;
Male
;
Middle Aged
;
Neoplasm Staging
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Organoplatinum Compounds/adverse effects/therapeutic use
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Retrospective Studies
;
Stomach Neoplasms/*drug therapy/mortality/pathology
;
Treatment Outcome
10.Phase I study of TPF neoadjuvant chemotherapy followed by radical radiotherapy in advanced nasopharyngeal carcinoma.
Ling GUO ; Huan-Xin LIN ; Min XU ; Qiu-Yan CHEN ; Cheng-Tao WANG ; Pei-Yu HUANG
Chinese Journal of Cancer 2010;29(2):136-139
BACKGROUND AND OBJECTIVEPF regimen is the standard chemotherapy for advanced head and neck cancers including nasopharyngeal cancer. Recently PF has been found to enhance the tumor control by addition of Taxotere. The purpose of this study was to evaluate the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) of TPF neoadjuvant regimen (taxotere, cisplatin (DDP) and 5-fluorouracil (5-FU)) followed by radical radiotherapy in advanced nasopharyngeal carcinoma (NPC).
METHODSBetween December 2006 and May 2008, 41 patients with newly diagnosed UICC stage III or IV advanced nasopharyngeal cancer were enrolled. There were 29 male and 12 female patients, with a median age of 47 years (range, 29-60 years), and ECOG performance status < or = 2. The initial dose was taxotere 40 mg/m(2) d1, DDP 40 mg/m(2) d1, and 5-FU 400 mg/m(2) d1-5. The treatment was repeated every 3 weeks for two cycles. Each dose of taxotere and DDP was increased by 5 mg/m(2) and 5-FU by 50 mg/m(2), respectively. The dose was escalated after six patients completed two cycles at the initial dose and DLT was assessed. Radiotherapy was started from the 5th week, with 68-72 Gy/34-36 fractions delivered to the nasopharynx and 60-66 Gy/30-33 fractions to the node-positive area.
RESULTSForty patients (79 cycles) were evaluated for toxicity and efficacy of the therapy. No DLT occurred at the dose levels 1-4. At dose level 5, three of six patients experienced DLT including grade III/IV neutropenia lasting more than 1 week. Two of them also had grade III mucositis, leading to the interruption of radiotherapy for more than 1 week. Three more new patients were retreated with the same dose (at dose level 6) under the G-CSF support, and no DLT occurred. Dose escalation continued to level 7, and DLT was found in all of the four patients, including three grade IV neutropenia, one of them had fever and pneumonitis; three grade III diarrhea; and one grade III mucositis lasting 10 days. Dose escalation was stopped and three more new patients were treated again at dose level 5 and no DLT was found. Other severe toxicities included grade III anemia (1 patients), grade III vomiting (4 patients), and grade III weight loss (9 patients). No severe hepatic and renal toxicities were found.
CONCLUSIONTPF neoadjuvant chemotherapy is a safe and effective regimen in the treatment of advanced NPC, with recommended doses of taxotere 60 mg/m(2) d1, DDP 60 mg/m(2) d1, and 5-FU 600 mg/m(2) d1-5.
Adult ; Antineoplastic Combined Chemotherapy Protocols ; adverse effects ; therapeutic use ; Cisplatin ; adverse effects ; therapeutic use ; Female ; Fluorouracil ; adverse effects ; therapeutic use ; Humans ; Male ; Maximum Tolerated Dose ; Middle Aged ; Mucositis ; chemically induced ; Nasopharyngeal Neoplasms ; drug therapy ; pathology ; radiotherapy ; Neoadjuvant Therapy ; Neoplasm Staging ; Neutropenia ; chemically induced ; Radiotherapy, High-Energy ; adverse effects ; Taxoids ; administration & dosage ; adverse effects ; therapeutic use