Comprehensive treatment with Chinese medicine in patients with advanced non-small cell lung cancer: A multicenter, prospective, cohort study / 中国结合医学杂志

<p><b>OBJECTIVE</b>To determine whether additional Chinese medicine (CM) could prolong survival and improve the quality of life (QOL) in patients with advanced non-small cell lung cancer (NSCLC) compared with Western medicine (WM) alone.</p><p><b>METHODS</b>This was a multicenter, prospective cohort study. A total of 474 hospitalized patients with stage III-IV NSCLC were recruited and divided into 2 groups. Patients in the WM group received radiotherapy, chemotherapy, and optimal supportive therapy according to the National Comprehensive Cancer Network (NCCN) guidelines. In the integrative medicine (IM) group, individualized CM (Chinese patent medicines and injections) and WM were administered. The primary end point was overall survival, and the secondary end points were time to disease progression, adverse events, and QOL. Follow-up clinical examinations and chest radiography were performed every 2 months.</p><p><b>RESULTS</b>The median survival was 16.60 months in the IM group and 13.13 months in the WM group (P<0.01). The incidences of loss of appetite, nausea, and vomiting in the IM group were significantly lower than those in the WM group (P<0.05). The QOL based on Functional Assessment of Cancer Therapy-Lung in the IM group was markedly higher than that in the WM group at the fourth course (P<0.05).</p><p><b>CONCLUSIONS</b>Additional CM may prolong survival and improve the QOL patients with NSCLC. The adverse effects of radio- and chemotherapy may be attenuated as CM is used in combination with conventional treatments.</p>

A Retrospective Study of Chinese Herbal Medicine Combined with Systemic Chemotherapy and/or Regional Arterial Perfusion for Pancreatic Cancer with Liver Metastases / 中国中西医结合杂志

<p><b>OBJECTIVE</b>To evaluate the efficacy and safety of Chinese herbal medicine combined with systemic chemotherapy and/or regional arterial perfusion for pancreatic cancer with liver metastases (PCLM).</p><p><b>METHODS</b>We retrospectively selected 292 patients with PCLM who were treated by Chinese herbal medicine combined with systemic chemotherapy and/or regional arterial perfusion at Tianjin Medical University Cancer Hospital from January 2001 to December 2010. All patients were assigned to the Western medicine treatment group (157 cases) and the integrative medicine treatment group (135 cases). Patients in the Western medicine treatment group were treated with gemcitabine (GEM)-based chemotherapy, and partial of them received regional arterial perfusion. Those in the integrative medicine treatment group additionally took Chinese herbs of clearing heat and eliminating mass for at least 4 weeks. The median survival time (MST) , adverse reactions and the incidence of complications were observed.</p><p><b>RESULTS</b>There was no statistical significance in general data between the two groups (P > 0.05). There was statistical difference in MST between the two groups (4.8 months vs 5.5 months, P < 0.05). No death occurred during chemotherapy or regional arterial perfusion. All toxic or adverse reactions were tolerable.</p><p><b>CONCLUSION</b>Chinese herbal medicine combined with systemic chemotherapy and/or regional arterial perfusion was effective and safe, and it could be optimally selected as palliative therapy for PCLM.</p>

An open-labeled, randomized, multicenter phase IIa study of gambogic acid injection for advanced malignant tumors / 中华医学杂志(英文版)

<p><b>BACKGROUND</b>Gambogic acid is a pure active compound isolated from the traditional Chinese medicinal plant gamboge (Garcinia morella Desv.). Based on the preliminary results of a phase I study, this phase IIa study compared the efficacy and safety of different dosage schedules of gambogic acid in patients with advanced malignant tumors.</p><p><b>METHODS</b>Patients with advanced or metastases cancer who had not received any effective routine conventional treatment or who had failed to respond to the existing conventional treatment were randomly assigned to receive either 45 mg/m(2) gambogic acid intravenously from Days 1 to 5 of a 2-week cycle (Group A), or 45 mg/m(2) every other day for a total of five times during a 2-week cycle (Group B). The primary endpoint was objective response rate (ORR).</p><p><b>RESULTS</b>Twenty-one patients assigned to Group A and 26 to Group B were included in the final analysis. The ORRs were 14.3% in Group A and 0% in Group B. It was not possible to analyze the significant difference because one of the values was zero. The disease control rates (DCRs) were 76.2% in Group A and 61.5% in Group B (P = 0.0456). The observed adverse reactions were mostly Grades I and II, and occurred in most patients after administration of the trial drug. There was no significant difference in the incidence of adverse reactions between the two arms.</p><p><b>CONCLUSIONS</b>The preliminary results of this phase IIa exploratory study suggest that gambogic acid has a favorable safety profile when administered at 45 mg/m(2). The DCR was greater in patients receiving gambogic acid on Days 1 - 5 of a 2-week cycle, but the incidence of adverse reactions was similar irrespective of the administration schedule.</p>

Analysis on the clinical and prognostic features of 71 male patients with breast cancer / 中华流行病学杂志

Objective Male breast cancer (MBC) is a rare disease,with clinical and prognostic features still controversial.The aim of this study was to discuss the clinical characteristics and prognosis of MBC.Methods Clinical data related to 71 MBC patients was reviewed.Results The radio of MBC to female breast cancer (FBC) was 42:10 000.Age related to the diagnosis of MBC ranged from 43 to 84 years with the median age as 62 years old,older than the FBC patients (t=6.355,P=0.000).The percentage of invasive ducal carcinoma in MBC patients was much higher than in FBC patients (x2=29.875,P=0.000).The positive rate of estrogen receptor (ER) was significantly higher than those in FBC patients and the positive rates of human epidermal growth factor receptor-2 (HER-2) were less frequently (x2=3.741,P=0.048 and x2=12.845,P=0.002)seen.Data from the univariate and multivariate analysis showed that the 3-,5-and 10-year survivalrates of MBC were 82.6％,74.0％ and 47.4％ respectively,significantly higher than those in FBCpatients (P=0.004,P=0.046).Patients with positive HER-2 showed worse prognosis than HER-2 negative patients in MBC patients (x2=4.219,P=0.040).Conclusion There were significant clinic-pathologic and prognostic differences between FBC and MBC patients.The HER-2 positivity seemed to be an important factor for the prognosis and treatment of patients with MBC.

Diagnosis and treatment of epithelioid sarcoma / 中华肿瘤杂志

<p><b>OBJECTIVE</b>To analyze the clinical features, diagnosis, treatment, and prognosis of epithelioid sarcoma (ES).</p><p><b>METHODS</b>The clinical data of 13 cases with epithelioid sarcoma in the Tianjin Medical University Cancer Institute and Hospital from March 1995 to December 2009 were collected and analyzed. There were 10 males and 3 females in the group, with an average age of 41.5 years (range: 13 to 68 years). Nine patients had classic ES and 4 had proximal-type ES. Surgery was the mainstay of treatment. After the operation, four patients received radiotherapy, five received chemotherapy, and one received chemoradiotherapy.</p><p><b>RESULTS</b>Of the 13 cases, only 1 had multi-locus lesion. The average tumor size was (6.07 ± 1.34) cm. The lymph node involvement was found in 46.2% of the patients. Local and distant failure occurred in 50% and 30% patients, respectively. The most common site for dissemination was the lung. Four cases died within 3 years after initial operation. The 1-, 2-, 5-, 10-year overall survival rates of the 11 cases were 72.7%, 54.5%, 27.3% and 9.1%, respectively, with a median survival time of 27 months.</p><p><b>CONCLUSIONS</b>Epithelioid sarcoma is a rare disease. The prognosis for patients with epithelioid sarcoma is poor because of a high propensity for local recurrence, lymph node metastases, and/or distant metastases. The definite diagnosis depends mainly on the pathologic examination. Wide surgical excision is the mainstay treatment, and radiation and chemotherapy have been used occasionally as adjuvant therapy but have had limited success.</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>

Clinical research on nourishing yin and unblocking meridians recipe combined with opioid analgesics in cancer pain management / 中国结合医学杂志

<p><b>OBJECTIVE</b>To investigate the analgesic effects of Nourishing yin and Unblocking meridians Receipe (NUR) combined with opioid analgesics in managing cancer pain.</p><p><b>METHODS</b>All the patients enrolled were differentiated as of yin deficiency and meridian blocked syndrome type of TCM. Forty-one of them in the treated group were treated with NUR combined with opioid analgesics, while 43 of them in the control group were given opioid analgesics alone with successive 14 days as one treatment course for both groups.</p><p><b>RESULTS</b>The indexes of the treated group were superior to those in the control group as to the degree of pain-relieving, the therapeutic effect of analgesia, the occurrence frequency of cancer pain every day and its duration each time, the analgesic initial time, and the quality of life.</p><p><b>CONCLUSION</b>NUR combined with opioid analgesics in cancer pain management was more effective than opioid analgesics alone.</p>

Transdermal fentanyl for the management of cancer pain: a survey of 4492 patients / 中华肿瘤杂志

<p><b>OBJECTIVE</b>To evaluate the efficacy and adverse effects of transdermal fentanyl in management of patients with cancer pain.</p><p><b>METHODS</b>A total of 4492 patients (aged 3-90) with cancer pain were enrolled in this multicenter study. The mean age was 58.5 (3 approximately 90) years old. All patients received transdermal fentanyl. The patients were asked to record the attacks of pain, quality of life, and any side effects of the treatment.</p><p><b>RESULTS</b>Baseline mean pain intensity was 7.37. On days 1, 3, 6, 9, 15, and 30, the mean scores of pain were decreased to 4.04, 2.98, 2.52, 2.19, 1.85 and 1.61, respectively (P < 0.01). The effective rate was 96.8%. The mean doses of fentanyl were 32.37 microg/h (25-200 microg/h) on the initial day, 42.57 microg/h and 49.57 microg/h (25-225 microg/h) on days 15 and 30. The quality of life was significantly improved after treatment (P < 0.01). The common side effects were constipation (9.8%), nausea (13.6%), dizziness (6.5%), vomiting (3.9%), sedation (2.0%) and respiratory depression (0.2%). The incidence of constipation was related to age, and the incidence of vomiting and difficulty of urination was related to gender. The majority (84.5%) of patients preferred continuation of the treatment with transdermal fentanyl.</p><p><b>CONCLUSION</b>Transdermal fentanyl for the patients with cancer pain is effective, safe, convenient and can improve the quality of life. Transdermal fentanyl can be recommended as one of first-line drugs for the treatment of patients with moderate to severe cancer pain.</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>

Clinical trial on exemestane in the treatment of postmenopausal women with advanced breast cancer / 中华肿瘤杂志

<p><b>OBJECTIVE</b>To evaluate the response rate and adverse reactions of exemestane (a new aromatase inactivator) in the treatment of postmenopausal women with advanced breast cancer.</p><p><b>METHODS</b>One hundred and seventy-three patients with advanced breast cancer entered this study with two patients excluded because of postmenopausal time being less than one year. Therefore, 173 patients could be evaluated for adverse events and 171 patients could be evaluated for efficacy. Exemestane, 25 mg orally daily for 4 weeks as one cycle was given.</p><p><b>RESULTS</b>In the 171 patients evaluated for efficacy, 4 (2.3%) experienced a complete response (CR) and 40 (23.4%) a partial response (PR), with the overall response rate of 25.7%. Ninety patients (52.6%) had stable disease (SD), with 25 having SD for at least 24 weeks. The clinical benefit (CR + PR + SD > or = 24 weeks) was shown in 69 (40.4%) patients. Progressive disease (PD) was shown in 37 (21.6%) patients. The untreated patients had a higher objective response rate (33.8%) than the retreated ones (18.1%) with significant difference (P = 0.019 7). The response rates for soft-tissue, bone involvement and visceral metastasis were 32.8%, 23.9%, and 12.4% (P = 0.002). There was no significant difference in different ages, time of menopause, disease-free interval or receptor status (P > 0.05). Drug-related adverse events were gastric discomfort (17.9%), malaise (17.9%), nausea (13.9%), hot flushes (11.0%) and dysphoria (5.8%). Other side reactions and abnormal laboratory parameters were observed occasionally which were irrelevant.</p><p><b>CONCLUSION</b>Exemestane can be used to treat postmenopausal women with advanced breast cancer giving only mild adverse reactions which are well tolerated.</p>