Analysis of the factors affecting pathologic complete response to neoadjuvant chemotherapy in breast cancer patients / 中华肿瘤杂志

<p><b>OBJECTIVE</b>To analyze the factors affecting pathologic complete response (pCR) to neoadjuvant chemotherapy (NAC) in breast cancer patients.</p><p><b>METHODS</b>A retrospective cohort study was carried out to analyze the clinical data of 141 breast cancer patients treated with neoadjuvant chemotherapy. The factors affecting pCR and the changes of tumor receptor status before and after treatment were analyzed.</p><p><b>RESULTS</b>Among all the 141 patients, 21 patients (14.9%) achieved pCR. The rate of pCR achieved by regimens of anthracycline combined with taxane was higher (16.8%, 19/113) than that by anthracycline-containing regimens (7.1%, 1/14). The dose intensity of anthracycline had a significant correlation with pCR rate (P < 0.05). The pCR rate in the relative dose intensity of taxane ≥ 0.85 arm was higher than that of < 0.85 arm (P = 0.02). Eighty patients (56.7%) had completed more than 4 cycles of chemotherapy and the median time to achieve pCR was 6 (3 to 10) cycles. The pCR rate had a significant difference between patients < 6 and ≥ 6 cycles (7.1% vs. 22.5%,P = 0.01). Multivariate analysis showed that tumor size measured by palpation ≤ 5 cm and ≥ 6 chemotherapy cycles were significantly related with pCR rate (P < 0.05). In all the 21 pCR patients, the pre-treatment ER(-), PR(-), HER-2(-) statuses were in 14, 14 and 17 patients, respectively. The status of ER, PR, HER-2 of most patients (74.2%, 69.7% and 87.7%, respectively) was not changed after treatment. Among the patients with changes in receptor status, ER changed from negative to positive was in the majority (37.1%, 13/35 vs. 12.9%, 4/31, P < 0.05), and the percentage of changes in PR and HER-2 status had no significant differences.</p><p><b>CONCLUSIONS</b>The regimens of anthracycline combined with taxane can achieve a higher pCR rate. The lymph node and receptor status before therapy have no significant correlation with pCR. Patients who have primary tumor size ≤ 5 cm, ≥ 6 chemotherapy cycles and enough dose intensity are easier to achieve pCR. The receptor status before and after therapy should be determined, and according to any positive results, physicians can chose HER-2 targeted therapy and/or endocrine therapy after surgery to benefit the patients.</p>

A clinical study of reasonable doses of docetaxel salvage therapy for patients with metastatic breast cancer / 中华肿瘤杂志

<p><b>OBJECTIVE</b>To evaluate the correlation of clinical effects and reasonable doses of docetaxel salvage therapy for patients with metastatic breast cancer.</p><p><b>METHODS</b>We reviewed retrospectively the clinical records of patients with metastatic breast cancer treated with docetaxel and statistically analyzed the correlation between clinical effects and reasonable doses of docetaxel.</p><p><b>RESULTS</b>The objective response rate and clinical benefit rate of docetaxol in patients with metastatic breast cancer were 27.0% and 35.0%, respectively, and the median progression free survival (PFS) was 5.0 (3.8 - 6.3) months. In the analysis at a single dose level, the clinical benefit rate and PFS of the ≥ 90.0 mg/m(2) docetaxel group were superior to that of the < 90.0 mg/m(2) group (P = 0.008, P = 0.045). Multi-dose level group stratified analysis showed that the docetaxel < 75.0 mg/m(2) group was better than the 75.0 - 84.9 mg/m(2) PFS group (P = 0.018), and the ≥ 95.0 mg/m(2) group was better than the 75.0 - 84.9 mg/m(2) group (P = 0.048). In patients who received >third line treatment or previously received paclitaxel adjuvant therapy, the PFS of the ≥ 94.9 mg/m(2) docetaxel group was 6.0 months, better than the 3.0 months of the 75.0 ∼ 84.9 mg/m(2) group (P = 0.031; P = 0.021).</p><p><b>CONCLUSION</b>There is a clear correlation between clinical effects and reasonable doses of docetaxel salvage therapy in patients with metastatic breast cancer.</p>

Efficacy and safety of regimens of capecitabine-based chemotherapy in the treatment of advanced breast cancer / 中华肿瘤杂志

<p><b>OBJECTIVE</b>To evaluate retrospectively the efficacy and toxicity of capecitabine-based chemotherapy in the treatment of advanced breast cancer.</p><p><b>METHODS</b>Three hundred and seventy-six patients with advanced breast cancer were treated with capecitabine-based chemotherapy regimens in our department from Sep 2002 to Sep 2009. They were divided into 3 groups. The group 1 was treated with capecitabine 1000 mg/m(2) orally twice daily on d1-d14, repeated every 3 weeks. The group 2 was treated with capecitabine as group 1, and combined with docetaxel 60 - 75 mg/m(2) intravenous infusion on d1, repeated every 3 weeks. The group 3 was treated with capecitabine as group 1, and combined with vinorelbine 25 mg/m(2) intravenous infusion on d1 and d8, repeated every 3 weeks. The median treatment period of treatment was 3 cycles.</p><p><b>RESULTS</b>Among the 376 patients, 218 patients were evaluable for response. In the group 1 the objective response rate (ORR) was 12.8% and the clinical benefit rate (CBR) was 21.6%. The CBR but not ORR of first line therapy with capecitabine was 35.2%, significantly higher than that of more than first line therapy (17.1%, P < 0.01). The ORRs for group 2 and group 3 were 53.8% and 36.4%, respectively. In the group 2 there was no significant difference in the ORR between the first line therapy and more than first line therapy. In the group 3 the ORR of first line therapy of NX regimen was 36.4%, significantly higher than that of more than first line therapy (16.7%, P < 0.01).</p><p><b>CONCLUSIONS</b>The capecitabine-based chemotherapy is effective and tolerable, and can be used not only in first line but also more than first line therapy. The single agent maintenance chemotherapy after response to combined chemotherapy can prolonge the duration of treatment for patients with metastatic breast cancer.</p>

Expression of Gemcitabine-resistance-related gene and polymorphism of ribonucleotide reductase M1 gene promoter in Gemcitabine-resistant A549/Gem and NCI-H460/Gem cell lines / 中华肿瘤杂志

<p><b>OBJECTIVE</b>To assay the expression of cytidine deaminase (CDA), ribonucleotide reductase subunit 1 (RRM1), phosphatase and tensin homologue deleted from chromosome 10 (PTEN), excision repair cross-complementation group 1 (ERCC1), deoxycytidine kinase (dCK) and RRM1(-)37A/C polymorphism, which have been shown relevant to gemcitabine resistance in two human gemcitabine-resistant non-small cell lung cancer cell lines A549/Gem and NCI-H460/Gem, so as to make clear how do they vary during the course of acquiring resistance to gemcitabine.</p><p><b>METHODS</b>The human gemcitabine-resistant non-small cell lung cancer cell lines A549/Gem and NCI-H460/Gem were established in our Department by repeated clinical serum peak concentration and gradually increasing doses. Real-time fluorescent quantitative PCR was used to examine the expression of CDA, RRM1, PTEN, ERCC1, dCK and RRM1(-)37A/C polymorphism in those cell lines at different time points during their induction process.</p><p><b>RESULTS</b>The resistance indexes of A549/Gem and NCI-H460/Gem cells reached 163.228 and 181.684, and then remained stable at 115.297 and 129.783, respectively. The expression of CDA, RRM1, PTEN and ERCC1 varied along with the changing gemcitabine resistance indexes, but expression of dCK did not change apparently. The wild type promoter was able to amplify the genomic DNA in different induction stages of A549/Gem and NCI-H460/Gem cells, but allelotype did not, indicating that the gene type of A549/Gem, NCI-H460/Gem and their parental cells remaining still wild type.</p><p><b>CONCLUSION</b>Compared with their parental cells, the expressions of CDA, RRM1, PTEN and ERCC1 in human gemcitabine-resistant non-small cell lung cancer cell lines A549/Gem and NCI-H460/Gem rise, the expression of dCK changes inapparently, therefore, their gene type are remaining wild type.</p>

Comparison of response evaluation methods of neoadjuvant chemotherapy in breast cancer patients / 中华肿瘤杂志

<p><b>OBJECTIVE</b>To compare the efficiency of response evaluation by clinical examination, ultrasonograghy and mammography in neoadjuvant chemotherapy (NAC) for breast cancer.</p><p><b>METHODS</b>A retrospective cohort study was conducted to analyze the data of 141 patients treated with neoadjuvant chemotherapy. Response evaluation was performed by clinical palpation, ultrasound and mammography.</p><p><b>RESULTS</b>Only 12 (8.5%) among the 141 patients presented with a stage I tumor. The tumor size determined by palpation was often larger than that by ultrasound before therapy (P < 0.01). Among patients with suspicions axillary nodes checked by ultrasound, 88.3% (53/60) of them had positive nodes by pathology before NAC, and 34.5% (10/29) of patients with negative nodes determined by ultrasound had positive nodes by pathology. In all the 141 patients, 21(14.9%) showed pathological complete remission in both the primary tumor and lymph node. For response evaluation, the false complete remission rate judged by clinical examination was 46.8% (22/47), and the false tumor residual rate by ultrasound was 84.0% (21/25). In 53.5% (23/43) of patients the response could not be assessed by mammography due to that the tumors were undistinguishable in size. The range of microcalcification was not reduced in 5 patients with a partial response of the tumor. 25 patients experienced needle puncture during therapy. Among them, in the 9 pathologically negative patients, only 3 achieved pCR, and the other 16 positive patients didn't achieve pCR.</p><p><b>CONCLUSION</b>Using the puncture or sentinel lymph node biopsy, clinicians should pay enough emphasis on the pathological determination of the node status before chemotherapy. Clinicians will make a quite of false judgment of the tumor by clinical examination, ultrasound or mammography. They may use needle puncture during therapy to evaluate the response of neoadjuvant chemotherapy, and the result should be analyzed synthetically.</p>

Combination with SN-38 on human colon cancer LoVo cells / 中华肿瘤杂志

<p><b>OBJECTIVE</b>To observe the anti-proliferation effect of bevacizumab and SN-38 (active metabolite of irinotecan), and investigate the possible mechanisms of these two agents.</p><p><b>METHODS</b>Human colon cancer LoVo cells were cultured under hypoxic conditions. Inhibition of cell proliferation was evaluated by MTT assay. The drug modulation on HIF-1alpha, VEGF, ERK and AKT were assessed by the following assays. The mRNA expression of HIF-1alpha and VEGF were measured by RT-PCR. The protein expression of HIF-1alpha, ERK and AKT were evaluated by Western blot analysis, and VEGF by ELISA assay.</p><p><b>RESULTS</b>Among different combination schedules, Bevacizumab given after SN-38 show most synergistic anti-proliferation effect. Under hypoxic conditions, the expression of HIF-1alpha and VEGF increased as time accumulated, Bevacizumab combined with SN-38 almost completely inhibited the expression of HIF-1alpha and VEGF. Moreover, the MAP kinase pathway was involved in the drug modulation of HIF-1alpha and VEGF.</p><p><b>CONCLUSION</b>These findings suggest the anti-proliferation effect of bevacizumab and SN-38 was schedule-dependent, and the synergistic effect of Bevacizumab and SN-38 was related to drug modulation of the HIF-1alpha and MAP kinase pathway.</p>

Phase III clinical study of zoledronic acid in the treatment of pain induced by bone metastasis from solid tumor or multiple myeloma / 中华肿瘤杂志

<p><b>OBJECTIVE</b>To evaluate the efficacy and safety of zoledronic acid in the treatment of bone pain in patients with bone metastasis from solid tumor or multiple myeloma.</p><p><b>METHODS</b>A randomized, double-blind, double-simulated and multi-center phase III clinical trail with pamidronate as control was conducted. Patients with moderate to severe bone pain (VAS > 50 mm) induced by solid tumor or multiple myeloma were randomized to receive intravenous zoledronic acid 4 mg or pamidronate 90 mg. Then the change of VAS and urinary NTX/Cr and CTX/Cr were observed in two groups.</p><p><b>RESULTS</b>From July 2005 to September 2006, 228 patients with bone pain induced by bone metastasis from 15 cancer centers were randomize into two groups: 116 patients in zoledronic acid group and 112 patients in pamidronate group. The VAS value was decreased gradually after treatment in these two groups. Significant improvement in bone pain after treatment were observed both in zoledronic acid group and the control group when compared with baseline VAS on D8 (-11.77% vs. -10.87%), D15 (-24.60% vs. -21.06%) and D28 (-32.37% vs. -31.26%) (P< or =0.0001), but no significant difference existed between two groups (P =0.6587). Compared with baseline, urine NTX/Cr and CTX/Cr level were decreased rapidly after treatment in both groups, the nadir was on D8, the median decreased on D28, which was -36.9% vs. -32.1% for NTX/Cr (P = 0.7922) and -63.2% vs. -47.9% for CTX/Cr (P =0.834). The frequently observed adverse events were pyrexia (19.0% vs. 31.3%), vomiting (6.0% vs. 8.9%), nausea (4.3% vs. 4.5%), fatigue (3.4% vs. 2.7%) and constipation (2.6% vs. 1.8%) in the two groups. Compared with baseline, the serum creatinine level was not significantly increased throughout the study.</p><p><b>CONCLUSION</b>Intravenous injection of 4 mg zoledronic acid can significantly reduce bone pain and bone resorption marker in urine in the Chinese patients with bone metastasis from solid tumor or multiple myeloma, which is tolerable and also comparable to pamidronate in the efficacy and safety.</p>

Polymorphisms of UGT1A gene and irinotecan toxicity in Chinese colorectal cancer patients / 中华肿瘤杂志

<p><b>OBJECTIVE</b>To assess the polymorphism of UGT1A gene in Chinese, and to investigate the correlation between UGT1A polymorphism and irinotecan toxicity in colorectal cancer patients.</p><p><b>METHODS</b>70 patients with advanced colorectal cancer were treated with irinotecan and 5-fluorouracil. Polymorphism analysis was performed in all those patients and 100 healthy subjects. Genomic DNA was extracted from peripheral blood and genotyped using polymerase chain reaction and direct sequencing.</p><p><b>RESULTS</b>14 patients exhibiting grade 3 - 4 neutropenia (20.0%), 16 patients experienced grade 2 - 4 diarrhea (22.9%), including only 4 patients with grade 3 - 4 diarrhea (5.7%). Compared with TA6/7 and TA7/7, UGT1 A1 * 28 wild genotype TA6/6 was significantly associated with reduced toxicity (42.1% vs. 15.7%, P = 0.027). There was no significant difference in the distribution of UGT1A genotypes between colorectal cancer patients and healthy subjects.</p><p><b>CONCLUSION</b>Chinese patients exhibit less irinotecan-related diarrhea due to higher frequence of UGT1A A1 * 28 wild genotype TA6/6.</p>

Safety and efficacy of gefitinib for treatment of advanced non-small cell lung cancer / 中华肿瘤杂志

<p><b>OBJECTIVE</b>To evaluate the safety and efficacy of gefitinib as second-line or even third-line treatment for previously treated patients with locally advanced or metastatic non-small cell lung cancer (NSCLC).</p><p><b>METHODS</b>156 patients with locally advanced NSCLC which were about to undergo progression after previous chemotherapy were eligible for this study. The regimen was oral intake of gefitinib 250 mg once daily in the morning or afternoon until the disease progression or toxicity has become intolerable. The drug was provided by AstroZeneca Company by its Expanded Access Program.</p><p><b>RESULTS</b>154 such patients were evaluable for response and toxicity assessment. The overall rate of objective response and disease control was 28.6% (44/154) and 89.6% (138/154). The median duration of response was 7. 5 months. The median time to disease progression (TTP) was 5. 1 months and the median overall survival time (OS) 10.0 months. The actuarial 1-year survival was 41. 0%. The response rate in adenocarcinoma was significantly higher than that in squamous carcinoma (P = 0. 026). The risk of disease progression in patients with squamous carcinoma was 1. 7 times as much as that of adenocarcinoma patients ( P = 0. 011) , and the risk of death in male was 2. 0 times as much as that in female ( P = 0. 002). At least one of these adverse events would be observed in 40.9% (63/154) of these patients, which, however was mild and reversible. Conclusion Gefitinib is effective and safe as a second-line or third-line treatment for previously treated patients with locally advanced or metastatic non-small cell lung cancer.</p>

EGFR mutation predicts response and prognosis in iressa-treated advanced-stage non-small cell lung cancer / 中华肿瘤杂志

<p><b>OBJECTIVE</b>To investigate the correlation between mutation in EGFR tyrosine kinase domain and tumor response as well as prognosis in advanced stage non-small cell lung cancer (NSCLC) treated with iressa.</p><p><b>METHODS</b>From May 2002 to Feb. 2005, iressa was orally administered at a dose of 250 mg once daily for 106 advanced stage NSCLC patients until occurrence of disease progression or intolerable toxicity. Cancer tissue was obtained from these patients, and DNA was extracted for analysis of mutation in exon 18 to 24 of EGFR. Exon 18 to 24 of EGFR were amplified by nest PCR, sequenced and analyzed from both sense and antisence directions.</p><p><b>RESULTS</b>Primary NSCLC tissue specimens consisted of 25 frozen tissue blocks and 81 paraffin-embedded tumor tissue blocks from 106 consecutive NSCLC patients. Mutation was found to be more frequent in the adenocarcinoma than in the squamous cell carcinoma (35.9% vs 14.3%, P =0.033). Mutation was identified in 32 patients (30.2%). Response rate to iressa was 71.9% in the patients with EGFR mutation versus 13.5% in those without mutation (P <0.01). Compared with the patients without EGFR mutation, those with mutation had longer overall survival (median, 13.45 vs. 5.25 months; P<0.01) and median time to progression (median, 8.35 vs. 3.0 months; P <0.01).</p><p><b>CONCLUSION</b>EGFR mutation may be positively correlated with the response and survival in advanced stage Chinese NSCLC patient treated with iressa.</p>

Effects of exogenous ER beta expression on the cell growth properties of MCF-7 breast cancer cell line / 中华肿瘤杂志

<p><b>OBJECTIVE</b>To study the effects of exogenous ER beta on the growth of breast cancer MCF-7 cells under different treatment.</p><p><b>METHODS</b>An eukaryotic expression vector containing 1.6 kb of human entire coding sequence of ER beta (pCDNA3-ER beta) was transfected into human breast cancer MCF-7 cells using lipofectamine 2000. The biological activity of ER beta was detected with the luciferase reporter containing estrogen responsive element (ERE) and the expression of ER beta protein by Western blot. The growth properties of MCF-7, pCDNA 3-transfected MCF-7 and pCDNA 3-ER beta-transfected MCF-7 cells under different treatment, including E2 (17beta-estradiol) and 4-OHT (4-hydroxytamoxifen), were observed.</p><p><b>RESULTS</b>A stronger activation of the reporter by ER beta in the presence of E2 was observed in the pCDNA 3-ER beta-transfected MCF-7 cells than in the pCDNA 3-transfected MCF-7 and in MCF-7 cells. Western blot analysis showed that the protein level of ER beta in the pCDNA 3-ER beta-transfected MCF-7 cells was markedly increased. Exogenous ER beta expression did not change the growth properties and the morphology of MCF-7 cells under normal condition. The pCDNA 3-ER beta-transfected MCF-7 cells proliferated at the same rate as naive cells in the presence of 4-OHT, whereas a strong inhibition of the proliferation of the pCDNA 3-ER beta-transfected MCF-7 cells in the presence of E2 was observed.</p><p><b>CONCLUSION</b>Exogenous ER beta expression does not increase the resistance to 4-OHT, and a strong inhibition of the proliferation may occur in the presence of E2.</p>

Expression of c-erbB2 protein and its relation to prognosis in 284 primary breast cancer patients / 中华肿瘤杂志

<p><b>OBJECTIVE</b>To investigate the expression of oncoprotein c-erbB2 in primary breast cancer and to analyze its relation to its prognosis.</p><p><b>METHODS</b>Immunohistochemical staining for c-erbB2 was performed on paraffin-embedded specimens of primary breast cancer from 284 patients, and the relation to its prognosis was statistically analyzed.</p><p><b>RESULTS</b>Positive expression rate of c-erbB2 was 26.8% (76/284) in 284 primary breast cancer patients. Expression of c-erbB2 was positively correlated with the status of lymph node metastasis (P = 0.003). Univariate analysis indicated that c-erbB2 expression is a significant prognostic factor for the disease-free survival (DFS) (P = 0.024) and overall survival (OS) (P = 0.002), while multivariate analysis demonstrated that c-erbB2 is an independent prognostic factor for OS (P = 0.023). Moreover, tumors with c-erbB2 positive expression are more tend to metastasis to other viscera than those with c-erbB2 negative. c-erbB2 expression has different prognostic values for patients with different status of estrogen receptor (ER) and lymph node metastasis.</p><p><b>CONCLUSION</b>c-erbB2 expression is an independent prognostic factor for total survival time in primary breast cancer patients, and its prognostic values are different according to the different ER status and lymph node metastasis.</p>

HER-2 and ER expression in prediction of chemo-sensitivity of taxane for advanced breast cancer / 中华肿瘤杂志

<p><b>OBJECTIVE</b>To investigate the predictive value of HER-2 and ER expression for chemosensitivity of taxane in the treatment of advanced breast cancer.</p><p><b>METHODS</b>Of 268 advanced breast cancer patients treated: 71 were by paclitaxel alone, 32 by docetaxel alone, 110 by paclitaxel combined with anthracylines or gemcitabine or platins and 55 by docetaxel-based combinations. HER-2 and ER expression of all patients treated by taxane underwent immunohistochemical (IHC) assay.</p><p><b>RESULTS</b>Univariate analysis showed: the response rate (RR) in HER-2 overexpression group was 56.7%, and in HER-2 weak expression group 33.3% (P = 0.003). The response rate in ER positive group and ER negative group was 33.3% and 48.9%, respectively, with a significant difference (P = 0.015). The RR was 67.6% in ER negative but HER-2 overexpression group. However, in ER positive but HER-2 weak expression group and the other groups, the RR were around 35% (P < 0. 01). Multivariate analysis showed that overexpression of HER-2 was the only significant factor to predict the chemosensitivity of taxane (P = 0. 007), but the ER, Karnofsky performance score (KPS), anthracylines, metastatic sites were not the statistically significant chemo-sensitivity predictive factors for taxane.</p><p><b>CONCLUSION</b>ER negative and/or HER-2 overexpression, especially latter, may be associated with good response in advanced breast cancers treated by taxane.</p>

Clinical study of zoledronic acid in the treatment of cancer-induced hypercalcemia / 中华肿瘤杂志

<p><b>OBJECTIVE</b>To investigate the effect and safety of zoledronic acid (Zoledex) in patients with cancer-induced hypercalcemia.</p><p><b>METHODS</b>Seventeen patients with cancer-induced hypercalcemia (corrected blood calcium > 2.70 mmol/L) were treated intravenously by 4 mg zoledex within 15 minutes on the first day. The corrected blood calcium was observed every 4 days in the following 28 days.</p><p><b>RESULTS</b>The response rate was 94.1% (16/17). The mean corrected blood calcium became normal after the first dose of zoledex (P < 0.01). The lowest value was found on the fourteenth day after treatment. The main side effects consisted of fever (29.4%, 5/17), hypocalcemic tetany (11.8%, 2/17) and arythmia (5.9%, 1/17).</p><p><b>CONCLUSION</b>Zoledex is effective and safe in the treatment of patient with cancer-induced hypercalcemia.</p>

Phase II clinical trial on China manufactured recombinant human interleukin-11 derivative in the prevention and treatment of chemotherapy-induced thrombocytopenia / 中华肿瘤杂志

<p><b>OBJECTIVE</b>This phase II clinical trial was designed to evaluate the efficacy and toxicity of recombinant human interleukin-11 (rhIL-11) derivative manufactured in China in the prevention and treatment of chemotherapy-induced thrombocytopenia in cancer patients.</p><p><b>METHODS</b>A total of 100 cancer patients with chemotherapy-induced thrombocytopenia (< or = 75 x 10(9)/L) were studied by self-cross control. Ninty-one of them received 2 cycles of chemotherapy. In the first cycle (control cycle) the patients received chemotherapy only, while in the second cycle (treatment cycle), the patients were given subcutaneous injection of rhIL-11 derivative (40 microg.kg(-1).d(-1)) once daily after chemotherapy for 10 consecutive days or more until platelet count reached > or = 300 x 10(9)/L.</p><p><b>RESULTS</b>1. The patients with platelet count of < or = 75 x 10(9)/L was 89/89 in the control cycle and 44/89 in the treatment cycle (P = 0.00). The recovery time to the normal platelet count was 1-47 days (median 9 days) in the control cycle, and 1-18 days (median 5.5 days) in treatment cycle (P = 0.00). 2. Patients with platelet count of < or = 50 x 10(9)/L was 56/89 in the control cycle and 20/89 in the treatment cycle (P = 0.00). The recovery time to normal platelet count was 1-31 days (median 9 days) in the control cycle and 3-13 days (median 6 days) in the treatment cycle (P = 0.05). 3. The median nadir platelet count was 44 x 10(9)/L (range: 10 x 10(9)/L-75 x 10(9)/L) in the control cycle, and 83 x 10(9)/L (range: 10 x 10(9)/L-310 x 10(9)/L) in the treatment cycle (P = 0.00). The time of recovery to the normal platelet count was 1-31 days (median 6 days) in the control cycle, and 0-13 days (median 2 days) in the treatment cycle (P = 0.00). 4. Nine of 89 evaluable patients required platelet transfusion in the control cycle versus 1 of 89 patients in treatment cycle (P = 0.01), and the total platelet transfusion was 10 times in the control cycle versus once in the treatment cycle (P = 0.01). 5. The major adverse events associated with rhIL-11 derivative were: headache, fatigue, myalgia/arthralgia, edema and palpitation, etc.</p><p><b>CONCLUSION</b>rhIL-11 derivative can be safely and effectively used for the prevention and treatment for chemotherapy-induced thrombocytopenia.</p>

Relation of dose intensity and efficacy, toxicity in paclitaxel as a single agent for advanced breast cancer / 中华肿瘤杂志

<p><b>OBJECTIVE</b>To evaluate the relation of dose intensity and efficacy, toxicity in advanced breast cancer treated with paclitaxel as a single agent.</p><p><b>METHODS</b>Seventy-one patients with advanced breast cancer received paclitaxel as a single agent with different dose intensities. According to the phase I or phase II trial, the standard dose intensity of paclitaxel was defined as 58.3 mg.(m(2))(-1).week(-1). The dose of paclitaxel was 175 mg/m(2) given every three weeks, ranging 33.3 - 70.3 mg.(m(2))(-1).week(-1) [median delivered dose intensity 58.82 mg.(m(2))(-1).week(-1)]. Efficacy and toxicity was evaluated.</p><p><b>RESULTS</b>The overall response rate in this group of advanced breast cancer was 40.8%. Responses were seen in lungs, soft tissue, bone and liver, with the response rates of 52.0%, 38.0%, 12.5%, 7.7%, respectively. When the relative dose intensity (RDI) was > 1.0, 0.9 - 1.0, < 0.9, the response rates were 44.2%, 47.6%, 0, respectively. The difference between the group (RDI >/= 0.9% - 1.0%) in 7 patients and the group (RDI < 0.9) was significant (P < 0.05). Toxicity was well tolerated, with the efficacy decreased as soon as the RDI had been reduced without embarrassing the toxicity.</p><p><b>CONCLUSION</b>Paclitaxel as a single agent therapy with standard dose intensity is effective and well tolerated by patients with advanced breast cancer.</p>

A prospective multicenter clinical trial of breast conserving therapy for early breast cancer in China / 中华肿瘤杂志

<p><b>OBJECTIVE</b>To demonstrate the feasibility of breast conserving therapy (BCT) and establish a multimodality BCT model for early breast cancer in China.</p><p><b>METHODS</b>A prospective multicenter case control study consisting of 4461 patients was carried out by the Cancer Hospital, Chinese Academy of Medical Sciences (CAMS) and nine other hospitals across China from November, 2001 to November, 2004, the result of BCT and mastectomy on early stage breast cancer were compared. Patients entry-primary tumor < or = 3 cm, primary tumor in periphery quadrant, pathology showed infiltrating carcinoma and clinical absence of locoregional lymphatic or distant metastasis. Patients rejection-multiple center cancer or diffused malignant calcified spots, previous radical radiation therapy in the chest, accompanying collogenolytic vascular granuloma and simultaneous pregnancy.</p><p><b>RESULTS</b>Of these 4461 patients, breast conserving surgery was performed in 872 (19.5%) patients who were eligible for BCT, accounting for 9.0% of all operated breast cancer patients during the same period. The rates of local recurrence, metastasis and death were 1.0% (9/872), 1.3% (11/872) and 0.1% (1/872) in BCT group, versus 0.5% (18/3589), 1.4% (49/3589) and 0.1% (4/3589) in the mastectomy group. No statistical significant difference was found between these two groups (P > 0.05). Cosmetic evaluation of breast in BCT group was carried out postoperatively at points of six months, one year and two years with 89.7%, 91.1% and 86.6% of the patients assessed as excellent or fine cosmetic state respectively.</p><p><b>CONCLUSION</b>Breast conserving therapy for early stage breast cancer is feasible in China, with no ominous effect on the survival and recurrence rate. Breast conserving therapy is able to improve not only the quality of life but also enhance the confidence of the patients, in addition to quasi-perfect cosmetic results. Standard comprehensive BCT involving multi-centers all concentrating on combination treatment should be widely adopted in China in the future. However, breast conserving surgery should selectively be used only for early stage breast cancer, and should be combined with postoperative radiotherapy, chemotherapy and hormone therapy in order to guarantee success.</p>

Comparison of endocrine therapy and chemotherapy for bone metastasis of breast cancer / 中华肿瘤杂志

<p><b>OBJECTIVE</b>To compare the efficacy of endocrine therapy with chemotherapy for bone metastasis of breast cancer.</p><p><b>METHODS</b>A total of 138 breast cancer patients with bone metastasis, but without visceral metastasis as retrospectively reviewed.</p><p><b>RESULTS</b>The response rates of endocrine therapy and chemotherapy as the first-line therapy were 35.4% and 31.7% (P = 0.687), and the total response rates were 27.1% and 25.0% (P = 0.690). The clinical benefit rates of endocrine therapy and chemotherapy as first-line were 43.9% and 36.6% (P = 0.437), as second-line were 47.8% and 24.2% (P = 0.033), in total treatments were 47.5% and 27.7% (P = 0.001). The median interval to treatment failure (TTF) was 5 months and 2 months (P < 0.001), and that to progression (TTP) was 5 and 2.5 months (P < 0.001) in endocrine therapy and chemotherapy group, respectively.</p><p><b>CONCLUSION</b>Endocrine therapy is superior to chemotherapy for bone metastasis of breast cancer.</p>

Single-agent Xeloda in the treatment of recurrent and metastatic breast cancer / 中华肿瘤杂志

<p><b>OBJECTIVE</b>To evaluate the efficacy and adverse reactions of Xeloda in the treatment of recurrent and metastatic breast cancer.</p><p><b>METHODS</b>This clinical study was designed to treat 69 patients with recurrent and metastatic breast cancer with Xeloda, 2500 mg/m(2)/d, twice daily for 2 weeks followed by a 1-week rest period, repeated every 3 weeks.</p><p><b>RESULTS</b>Sixty-nine patients received Xeloda for more than 1 cycle. The overall response rate (CR + PR) was 16.0%, clinical benefit rate (CR + PR + SD > or = 24 months) was 27.5%, disease control rate (CR + PR + SD) was 75.4%. The median time to failure (TTF) was 3 months (range: 0.7 - 11 months). The median time to progression (TTP) was 2 months (range: 0.7 - 11 months). The median duration of response (CR + PR) was 6 months (range: 4 - 11 months). The most common treatment-related adverse events were hand-foot syndrome (HFS) that occurred in 60.8% (42/69) patients mostly as grade I-II. Fifty-five percent (22/40) of patients who had received high dose preventive Vit B6 developed HFS without grade III; while 69% (20/29) of patients who had not received such treatment did develop HFS including 2 patients with grade III. However, there was not significant difference between the two groups.</p><p><b>CONCLUSION</b>Xeloda is an effective and well tolerated treatment in patients with recurrent and metastatic breast cancer. The symptoms of HFS may be relieved by high dose Vit B6 as prevention.</p>

Herceptin as a single agent in patients with HER2 overexpressing metastatic breast cancer / 中华肿瘤杂志

<p><b>OBJECTIVE</b>To evaluate the efficacy and adverse reactions of Herceptin as a single agent in patients with HER2 overexpressing metastatic breast cancer.</p><p><b>METHODS</b>There were two kinds of therapy protocol. One was loading-dose of 4 mg/kg intravenously, followed by a 2 mg/kg maintenance dose of weekly intervals. The other was loading-dose of 8 mg/kg, followed by 6 mg/kg of every three weeks intervals.</p><p><b>RESULTS</b>Among 20 patients with evaluated efficacy, there was no complete response, 5 patients (25.0%) showed partial response (PR), 5 (25.0%) stable disease (SD) and 10 (50.0%) progressive disease (PD). Of 22 patients, the overall response rate was 22.7%. The median time of disease progression and treatment failure was 6 weeks and 6.5 weeks, respectively. The most common adverse reactions were fever and chill. Cardiac symptoms could be seen in some patients.</p><p><b>CONCLUSION</b>Herceptin is an active agent for the patients with HER2 overexpressing metastatic breast cancer and the adverse events are well tolerated.</p>