High dose chemotherapy and autologous stem cell transplantation as adjuvant therapy for primary breast cancer patients with four or more lymph nodes involved: long-term results of an international randomised trial.

BACKGROUND: The purpose of this study was to assess whether a short course of anthracycline containing chemotherapy followed by high dose therapy with autologous stem-cell support improves disease-free and overall survival as compared with conventional, anthracycline containing chemotherapy, in patients with primary breast cancer and four or more histologically involved lymph nodes. PATIENTS AND METHODS: Two hundred and eighty one patients entered into a randomised clinical trial were allocated to receive standard, conventional treatment (5-fluorouracil, epirubicin and cyclophosphamide-FEC for six cycles) or FEC for three cycles followed by high dose therapy consisting of cyclophosphamide, thiotepa and carboplatin and stem cell rescue (HDT). To be eligible, patients had to be free of overt metastatic disease and be < or =60 years of age. Analyses were according to intention to treat. RESULTS: At a median follow up of 68 months, 118 patients have experienced a relapse or death from breast cancer (62 in the FEC followed by HDT arm and 56 in the conventional FEC arm) and a total of 100 patients have died (54 in the FEC followed by HDT arm and 46 in the conventional FEC arm). No significant difference was observed in relapse-free survival [hazard ratio 1.06, 95% CI 0.74-1.52, p = 0.76] or overall survival [hazard ratio 1.18, 95% CI 0.80-1.75, p = 0.40]. Five patients died from treatment related causes, three as a consequence of HDT and two in the conventional FEC arm. CONCLUSIONS: At the present time, no benefit has been observed from replacing three cycles of conventional chemotherapy with the HDT regimen described here. Patients should continue to receive conventional chemotherapy as adjuvant therapy for breast cancer.     

Breast cancer patients with 10 or more involved axillary lymph nodes treated by multimodality therapy: influence of clinical presentation on outcome

PURPOSE: To analyze tumor control and survival for breast cancer patients with 10 or more positive lymph nodes without systemic disease, treated by adjuvant radiation alone or combined-modality therapy. METHODS AND MATERIALS: We reviewed the records of 309 consecutive patients with these characteristics who received locoregional radiotherapy (RT) at our institution. The majority of patients had clinical Stage II or IIIA-B disease (43% and 48%, respectively). The median number of positive axillary lymph nodes was 15 (range, 10-78). Adjuvant therapy consisted of RT alone, with or without chemotherapy, tamoxifen, and/or ovarian castration. RESULTS: The overall 5-year and 10-year disease-free survival (DFS) rates were 20% and 7%, respectively. Median DFS was higher for patients with Stage I-II compared with those with Stage IIIABC (28 vs. 19 months; p = 0.006). Median DFS for patients aged 相似文献   

A dose escalation trial of adjuvant cyclophosphamide and epirubicin in combination with 5-fluorouracil using G-CSF support for premenopausal women with breast cancer involving four or more positive nodes.

BACKGROUND: Dose-dense and dose-intensive regimens have improved the outcome of breast cancer in high-risk women with operable disease. PATIENTS AND METHODS: Sixty-three premenopausal women with Stage 2, 3 breast cancer and > or =4 positive axillary nodes were treated in three successive cohorts with 70 mg/m(2) of epirubicin, 500 mg/m(2) of 5-fluorouracil and G-CSF every 14 days for 12 cycles. Cyclophosphamide (C) was given at 700 mg/m(2), 900 mg/m(2), and 1100 mg/m(2) doses. Patients were evaluated for dose-limiting toxicities (DLTs) in the first four cycles, the primary endpoint of the trial. RESULTS: No DLTs were seen at C 700 mg/m(2); at C 900 mg/m(2) two of 16 patients experienced febrile neutropenia and poor performance status; at C 1100 mg/m(2), 1 of 31 patients experienced poor performance status. Over 6 months, febrile neutropenia, grade 4 thrombocytopenia, grade 3 anemia and severe fatigue were observed. Clinical congestive heart failure occurred in three patients over 4 years. CONCLUSION: A dose-intense and dose-dense regimen of cyclophosphamide, epirubicin and 5-fluorouracil was delivered with G-CSF without apparent increase in acute toxicity. Cyclophosphamide could be increased to more than twice the standard dose at the cost of more anemia and fatigue.     

Dose-intensified chemotherapy for breast cancer: Present and future prospects

With the trend to maximize chemotherapy in breast cancer, the use of peripheral blood stem cells in addition to hematopoietic growth factors to alleviate myelosuppression caused by dose-intensified chemotherapy has been shown to be beneficial. In treatment of metastatic breast cancer, response rates and complete response rates as high as 100% and nearly 80%, respectively, have been reported. Such treatments have shown even greater promise in an adjuvant setting for high-risk breast cancer. High-dose chemotherapy studies, however, involve highly-selected patient populations who are generally compared with unselected patients, and controversy still surrounds the question of whether it is substantially superior to conventional-dose chemotherapy. There are now more than sufficient data to justify ongoing randomized trials, and the most important overall recommendation is to encourage patients to participate in these clinical trials.     

淋巴结转移10枚及以上的原发乳腺癌回顾性研究

目的：回顾性分析10枚及以上腋窝淋巴结转移原发乳腺癌各临床病理因素、辅助治疗方法与预后的关系。方法：对病理确诊且腋窝淋巴结转移10枚及以上原发乳腺癌患者186例，采用X^2检验和COX模型，分析诊断年龄、肿物大小、临床分期、术式、术前化疗状态、术后化疗状态、术后放疗状态、术后内分泌治疗状态、受体状态与预后的关系。结果：临床病理因素和辅助治疗方法与3、5年复发率和3、5年转移率差异均无统计学意义，P〉0．05。肿物大小与10年生存率、5年和10年无瘤生存率差异均有统计学意义，P〈0．05。临床分期10年无瘤生存率差异有统计学意义（P=0．030），而与5、10年生存率和5年无瘤生存率差异均无统计学意义，P〉0．05。术后辅助化疗、术后辅助放疗和术后辅助内分泌治疗5、10年无瘤生存率及5、10年生存率差异均有统计学意义，P〈0．05。诊断年龄、术式、激素受体状态和术前化疗状态与5年无瘤生存率、10年无瘤生存率及5、10年生存率差异均无统计学意义，P〉0．05。COX模型分析结果仅术后化疗状态是与预后相关的辅助治疗方法。结论：对于10枚及以上淋巴结转移原发乳腺癌其预后与临床病理因素和辅助治疗的选择相关。     

Aldehyde dehydrogenase 1-positive cells in axillary lymph node metastases after chemotherapy as a prognostic factor in patients with lymph node-positive breast cancer

BACKGROUND:

Aldehyde dehydrogenase 1 (ALDH1)‐positive cells exhibit stem‐like or progenitor ability and have been considered a clinically important diagnostic and therapeutic target in patients with breast cancer. In this study, the authors evaluated responsiveness to chemotherapy of ALDH1‐positive cells in primary and metastatic lesions and its relation to prognosis for patients with lymph node‐positive breast cancer.

METHODS:

In total, 115 patients who had breast cancer with cytologically confirmed lymph node metastases and who underwent surgery after neoadjuvant chemotherapy (NAC) were evaluated. By using ALDH1 immunohistochemistry in core‐needle biopsy specimens of the primary tumor, cytology samples of axillary lymph nodes before NAC, and pathologic samples of each after NAC, the clinical significance of ALDH1‐positive cell status was evaluated in primary and metastatic lesions before and after NAC.

RESULTS:

The presence of ALDH1‐positive cancer cells, but not ALDH1‐negative cancer cells, in primary and metastatic lesions after NAC was associated with a worse prognosis. In multivariate analysis, only ALDH1‐positive cells in metastatic lesions after NAC correlated with overall survival. The responsiveness of ALDH1‐positive cells to chemotherapy differed between primary and metastatic lesions, and the findings indicated that ALDH1‐positive cells in metastatic lesions after NAC may clinically precede those in the primary lesion.

CONCLUSIONS:

The responsiveness of ALDH1‐positive cells to chemotherapy in primary and metastatic lesions and its prognostic significance were clarified in patients with breast cancer. The authors concluded that ALDH1‐positive status may represent a surrogate marker as a new concept in patients with lymph node‐positive breast cancer. Cancer 2012. © 2011 American Cancer Society.     

Weekly TP regimen as a postoperative adjuvant chemotherapy for completely resected breast cancer in China: final result of a phase II trial

Objectives: To investigate the safety and long-term survival with weekly paclitaxel combined with cisplatin (wTP) as a postoperative adjuvant chemotherapy regimen for breast cancer. Methods: Patients with breast cancer were treated postoperatively with paclitaxel 40 mg/m2 intravenously on days 1, 8 and 15, cisplatin 25 mg/m2 also intravenously on days 1,8 and 15, repeated every 21-28 days as a cycle. Toxicity and survival rate were evaluated after chemotherapy. Results: Between September 1993 and August 2001, 20 patients were enrolled. Median age was 52 years (range, 35–71 years). According to the TNM stage system, all patients were staged Ⅱ or Ⅲ. Median number of chemotherapy cycles was 3 (range, 1–6), and 10 patients received 4 to 6 cycles of wTP. After a median follow-up of 83 months, 2 deaths and 6 relapses were documented. The five year overall survival rate was 90%. All patients could be evaluated with regard to toxicity. No treatment related deaths were recorded. Neutropenia occurred in 75% of patients during treatment, all recovering after G-CSF injection. Other symptoms included nausea/vomiting, elevation of transaminase, urea nitrogen/creatinine and alopecia. Conclusions: wTP is safe and effective at the doses tested. However, a randomized clinical trial is needed to compare wTP with other conventional adjuvant regimens of breast cancer postoperatively.     

乳腺癌新辅助化疗10年预后的影响因素分析

目的:分析乳腺癌新辅助化疗患者的预后及影响因素。方法:回顾性分析302例乳腺癌新辅助化疗患者的临床资料,进行单因素和多因素分析影响预后的因素。结果:全组患者10年生存率为70.5%。多因素分析表明,新辅助化疗的近期疗效、是否三苯氧胺治疗、腋窝淋巴结临床及病理分期与患者的10年生存期有关。结论:新辅助化疗的近期疗效、是否三苯氧胺治疗、腋窝淋巴结临床及病理分期是影响乳腺癌新辅助化疗患者10年预后的独立因素。     

Radiotherapy after high-dose chemotherapy and peripheral blood stem cell support in high-risk breast cancer

To assess the toxicity and efficacy of radiotherapy with respect to locoregional control after adjuvant high-dose chemotherapy for patients with breast cancer. At first, radiotherapy was withheld because of toxicity concerns, but it was introduced in 1995 because of reported high locoregional relapse rates.

Between 1992 and 1998, 40 patients with Stage II–III high-risk breast cancer received adjuvant high-dose chemotherapy consisting of thiotepa, mitoxantrone, and cyclophosphamide and peripheral blood stem cell support after four cycles of induction chemotherapy. The chest wall or breast, as well as the supraclavicular nodes, were irradiated with electrons and photons to a median dose of 50.4 Gy in 20 patients. Six additional patients received only supraclavicular irradiation to a median dose of 50.4 Gy. Acute toxicity was scored clinically. Pulmonary function tests were performed in 14 irradiated patients before high-dose chemotherapy and 1.1–4.4 years (median 1.6) after irradiation. The median follow-up time of living patients was 33 vs. 67 months in irradiated (n = 26) and nonirradiated (n = 14) patients, respectively.

G2 and G3 hematologic toxicity occurred in 1 patient each. No clinical pneumonitis or clinical impairment of lung function was observed. After 1–2 years, the lung function tests showed only minor changes in 4 patients. The 3-year locoregional control rate was 92% in the irradiated patients vs. 58% in the nonirradiated patients (p = 0.049, actuarial analysis).

In this series, adjuvant radiotherapy after adjuvant chemotherapy for breast cancer appeared well tolerated, with improved local regional control and without significant side effects. Longer follow-up and more patient accrual, as well as Phase III trials, are necessary for confirmation.     

Ovarian protection with goserelin during adjuvant chemotherapy for pre-menopausal women with early breast cancer (EBC)

PURPOSE: Ovarian failure and infertility following adjuvant chemotherapy for early breast cancer are major concerns for some young women. Techniques for oocyte harvesting are associated with delay in starting treatment, potentially undesirable estrogen stimulation and a relatively low success rate. We report an audit of our experience with the luteinising hormone-releasing hormone agonist, goserelin, to achieve transient ovarian suppression during chemotherapy as a means of preserving ovarian function. PATIENT AND METHODS: Pre-menopausal women were offered goserelin 3.6 mg by subcutaneous injection every 28 days during chemotherapy, starting 0-14 days prior to treatment. The primary end-point was recovery of menstruation. Serum luteinising hormone, follicle stimulating hormone and oestradiol were measured at recovery of menstruation or at first year follow-up if amenorrhoea persisted. Subsequent pregnancies were recorded. RESULTS: Fifty-one evaluable women were audited. Amenorrhoea occurred in all but one. All received combination anthracycline-containing chemotherapy regimens with a mean cumulative cyclophosphamide dose of 3.9 g/m(2). Forty-five (90%) recovered menstruation during the first year of follow-up; mean time to recovery 5 months. Eight pregnancies in 10 women attempting this so far. CONCLUSION: Using goserelin concurrently with chemotherapy is associated with a high rate of ovarian function preservation.     

Time to initiation of adjuvant chemotherapy in patients with rapidly proliferating early breast cancer

AimTo evaluate the optimal time interval from definitive surgery to commencing chemotherapy in early breast cancer (EBC).Patients and methodsThe relationship between time to initiation of adjuvant chemotherapy (TTC), calculated in weeks, and disease-free (DFS) or overall survival (OS), was assessed in 921 EBC patients with rapidly proliferating tumours (thymidine labelling index >3% or G3 or Ki67 >20%), randomised in a phase III clinical trial (NCT01031030) to receive chemotherapy with or without anthracyclines (epirubicin → cyclophosphamide, methotrexate and fluorouracil (CMF) versus CMF → epirubicin versus CMF). DFS, OS and 95% confidence intervals (95% confidence interval (CI)) were calculated by the Kaplan–Meier method. Multivariate Cox analysis was performed in relation with nodal involvement, oestrogen receptor and human epidermal growth factor receptor 2 (HER2) status, Ki67 value, type of adjuvant chemotherapy, menopausal status and tumour size.ResultsAt a median follow-up of 105 months (range 2–188), a prolonged TTC resulted in a significant increase in the risk of relapse: hazard ratio (HR) 1.15 (95% CI 1.02–1.30, p = 0.019). Using a backward elimination procedure, TTC, tumour size and nodal involvement remained significantly associated with DFS. A time-dependent receiver-operating characteristic (ROC) curve analysis was subsequently utilised to evaluate the best cut-off for TTC, identifying 7 weeks as the best threshold for longer OS (p = 0.043): 8-year OS 88% (95% CI 85–90) for patients with a TTC <7 weeks and 78% (95% CI 68–87) for the other group.ConclusionsOur results confirm that a shorter TTC may reduce relapses and possibly also improve clinical outcome in patients with highly proliferating EBC.     

Involvement of three or more lymph nodes predicts poor prognosis in submucosal gastric carcinoma

BACKGROUND: Multivariate analyses has shown that the status of lymph node metastasis and the depth of tumor penetration through the gastric wall are the most important prognostic factors in patients with advanced gastric carcinoma after curative operation. A clinicopathological study was carried out to clarify a simple and optimal prognostic indicator for early gastric cancer. METHODS: Retrospective analyses of 982 patients with early gastric cancer (562 with mucosal [M] and 420 with submucosal [SM] tumor) treated by gastrectomy with D2 lymph node dissection were performed. RESULTS: The incidence of lymph node metastasis from M and SM tumors was 2.5% (14/562) and 20.2% (85/420), respectively. There were no apparent prognostic indicators in patients with M tumors. In patients with SM tumors, the cancer-specific 5-year survival of those with lymph node metastasis was significantly lower than that of those without such metastasis (77.6% vs 98.2%; P < 0.001). An sharp decrease in survival was seen between patients with two positive nodes and those with three positive nodes, and the cancer-specific 5-year survival rate of patients with three or more metastatic lymph nodes was significantly lower than that of those with one or two nodes (P < 0.001; univariate analysis). Multivariate analysis revealed that the involvement of three or more lymph nodes was the sole independent prognostic determinant (P = 0.016); the level of nodal metastasis was not an independent prognostic factor (P = 0.384). All patients with N2 lymph node echelons (according to the Japanese Research Society for Gastric Cancer classification of the draining lymph nodes of the stomach) in the group with one or two positive nodes survived for more than 5 years. CONCLUSION: The sole independent prognostic factor in SM gastric cancer is the involvement of three or more metastatic lymph nodes. We suggest that this simple prognostic indicator for the follow-up of early gastric cancer, and this could lead to potentially effective adjuvant chemotherapy.     

Efficacy of Dose Dense Doxorubicin and Cyclophosphamide Followed by Paclitaxel versus Conventional Dose Doxorubicin,Cyclophosphamide Followed by Paclitaxel or Docetaxel in Patients with Node-Positive Breast Cancer

Background: Adding taxanes to adjuvant antracycline and cyclophosphamide (AC) in combination mayprovide significant improvement in node-positive and high risk node-negative breast cancer (BC) patients.However, the optimal dose and the role of dose-dense (DD) chemotherapy have yet to be determined. The aimof this study was to compare the efficacy of a DD paclitaxel (P)-AC combination with conventional weekly P-ACor docetaxel D-AC combinations in patients with node-positive breast cancer. Materials and Methods: Newlydiagnosed 280 node-positive BC patients diagnosed from 1998 to 2013 in three clinics were retrospectivelyanalyzed. Demographic and medical data were collected from the medical charts. Patients were categorizedto 3 groups according to treatment arms: arm A, ddAC-P; arm B, weekly P and AC combination; and arm C;T and AC combination. Adjuvant trastuzumab was added for HER2-positive patients. Kaplan-Meier survivalanalysis was carried out for disease free survival (DFS) and overall survival (OS). The log-rank test was usedto examine the statistical significance of the differences observed between the groups. Two-sided P values <0.05were considered statistically significant. Results: Of the total of 280 patients, 101 were in arm A, 114 in arm Band 65 in arm C.The median ages were 49, 50 and 46, respectively (p=0.11). Median follow-up was 39 (3-193)months. Stage, lymphovascular and perineural invasion, receptor patern, and menopausal status were similar inthe 3 treatment arms, but HER2 positivity was significantly lower in arm A, compared to arms B and C (25.7%,53.1%, 41.5% in arms A, B and C, respectively; p<0.001). Also grade 3 tumors were significantly less frequentin treatment arm A compared to arm B and C (27.3%, 56.8% and 49.2% , respectively, p=0.01). Afterunivariateand multivariate analysis were performed, 3-year DFS rates were 89%, 81%, and 75%, respectively (p=0.12) andthree year OS rates were 96.6%, 89%, and 75% (p=0.62). Conclusions: In this study, no significant differencewas found between adjuvant dose dense and conventional taxane treatment regimens.     

Taxane-Based Regimens as Adjuvant Treatment for Breast Cancer: a Retrospective Study in Egyptian Cancer Patients

Background: To evaluate the impact of adding taxanes to anthracycline-based regimens in the adjuvant settingin localized young female breast cancer patients on the overall survival (OS) and the disease free survival (DFS).Materials and Methods: This retrospective study included all female breast cancer patients who were candidatesfor adjuvant chemotherapy presenting to Kasr Al Ainy centre of clinical oncology and Cairo oncology centre(Cairo Cure) in the period from January 2005 till December 2010. Results: Our study included 865 patients, 732of whom received anthracycline based regimens and 133 taxane based regimens. The mean age of patients was39 years. After a median follow up of 50 months the median DFS was 48.4 months. Survival analysis indicatedthat the tumor size (>5cm vs. <5cm) p=0.001), nodal involvement (Yes vs. No) p=0.0001) and pathology (invasivelobular vs. ductal) p=0.048) affected DFS. As regards hormonal status, ER, PR and HER 2neu positive patientshad longer DFS (p=0.001, 0.003, 0.106). On multivariate analysis DFS was affected by tumor size and lymph nodeinvolvement (p=0.014, 0.007). Subgroup analysis showed improvement in arms treated with taxanes in terms ofDFS with positive Her2neu, ER and PR, but this was not statistically significant. Conclusions: Adding adjuvanttaxanes to anthracyclines is beneficial for treatment of localized breast cancer among all subgroups, especiallyhigher risk groups .The type of adjuvant chemotherapy regimens and tumor characteristics have direct effectson DFS.     

A prospective study of adjuvant CMF in males with node positive breast cancer: 20-year follow-up

Purpose To determine the long-term overall survival of male patients with stage II node positive breast cancer treated with adjuvant chemotherapy. Patients and methods Between 1974 and 1988, 31 male breast cancer patients were prospectively enrolled on study MB-82 in the National Cancer Institute. Following mastectomy, patients were treated with 12 cycles of cyclophosphamide, methotrexate, and fluorouracil (CMF) chemotherapy. Results Median patient age was 61 years (38–74 years). Twenty-one patients (68%) had 1–3 positive axillary lymph nodes while ten patients (32%) had four or more positive nodes. Estrogen receptor status was positive in 22 (71%), negative in 1 (3%), and unknown in 8 (26%) tumors. Progesterone receptor status was positive in 18 (58%), negative in 3 (10%), and unknown in 10 (32%) tumors. Median potential follow-up for all patients is 22.5 years with a median survival of 16.3 years. Twenty-one of 31 patients have died; one from a treatment-related complication, nine patients from recurrent breast cancer, five from other cancers, one from non-cancer related causes, and five from unknown causes. Ten patients remain alive at a median of 19.2 years. The overall survival probability at 10 years is 64.5% (95% CI: 46.9–78.9%), at 15 years is 51.6% (95% CI: 34.8–68%), and at 20 years is 42.4% (95% CI: 25.8–60.8%). Conclusion To our knowledge, 20-year prospective data with adjuvant chemotherapy in male breast cancer has never been reported. Adjuvant chemotherapy may benefit male breast cancer patients with positive nodes. The U.S. Government's right to retain a non-exclusive, royalty-free license in and to any copyright is acknowledged.     

The effect of postoperative radiotherapy on the feasibility of optimal dose adjuvant CMF chemotherapy in stage II breast carcinoma

The impact of a number of variables upon the effectiveness of adjuvant chemotherapy given to 87 patients with Stage II breast carcinoma was retrospectively analyzed. Adjuvant chemotherapy consisted of cyclophosphamide, methotrexate and 5-fluorouracil (CMF). Drugs were given in optimal doses (85% or more of the planned dose) to 17% of the patients; in intermediate doses (66 to 84% of the planned dose) to 50% of the patients; and in low doses (65% or less of the planned dose) to 33% of the patients. Myelosuppression was the main reason for giving intermediate or low doses. At a median follow-up of three years, 84% of all patients remain alive. Radiation therapy preceding chemotherapy was given to 70 % of the patients, concomitant irradiation and chemotherapy to 15 %, and 13 patients (15%) received chemotherapy only. Of the 14 patients who received optimal doses of CMF, 12 (86%) also received radiation therapy. Disease-free survival at three years is similar for irradiated and nonirradiated patients, but the latter have a higher incidence of local recurrence (5 % vs. 15 %), although the difference is not statistically significant. Delay in the initiation of chemotherapy, mostly because of the administration of postoperative irradiation, adversely affected the probability and duration of disease-free survival, particularly in premenopausal women in whom chemotherapy was started within more than 90 days of mastectomy. The administration of optimal doses of adjuvant chemotherapy should follow the primary treatment to the breast tumor as closely as possible. If radiation therapy is indicated as well, it should be delivered concomitantly with chemotherapy, given the feasibility of administering both modalities simultaneously, as demonstrated in this study.     

Peripheral blood circulating cytokeratin-19 mRNA-positive cells after the completion of adjuvant chemotherapy in patients with operable breast cancer.

BACKGROUND: The purpose of this study was to evaluate the prognostic significance of the molecular detection of cytokeratin 19 (CK-19) mRNA-positive cells in the peripheral blood of women with operable breast cancer after the completion of adjuvant chemotherapy. PATIENTS AND METHODS: Blood from 161 patients with stage I and II breast cancer, obtained after the completion of adjuvant chemotherapy, was tested by nested RT-PCR for CK-19 mRNA detection. Using univariate and multivariate analyses possible interactions with other prognostic factors and association of CK-19 mRNA detection with risk of relapse, disease-free interval (DFI) and overall survival were investigated. RESULTS: After completion of adjuvant chemotherapy, 27.3% of patients had peripheral blood CK-19 mRNA-positive cells; there was no association of this finding with any other prognostic factors or the type of chemotherapy regimen used. For patients with less than four involved axillary lymph nodes the risk of relapse was 3.81 [95% confidence interval (CI) 1.06-13.71] times higher, and the DFI was significantly reduced (P = 0.028) if CK-19 mRNA-positive cells were detectable in the blood after the completion of adjuvant chemotherapy. In contrast, for patients with four or more involved lymph nodes, the presence of CK-19 mRNA-positive cells after adjuvant chemotherapy did not significantly affect the risk of relapse or DFI. Furthermore, the risk of relapse was higher (hazards ratio 3.70; 95% CI 1.09-13.89) and the DFI was reduced (P = 0.022) for patients with detectable CK-19 mRNA-positive cells following adjuvant cyclophosphamide, methotrexate and 5-fluorouracil (CMF) as compared with epirubicin, cyclophosphamide and 5-fluorouracil (FEC) or sequential taxotere-epirubicin and cyclophosphamide (T/EC) chemotherapy. CONCLUSIONS: The detection of CK-19 mRNA-positive cells in the peripheral blood after adjuvant chemotherapy may be of clinical relevance for patients with early breast cancer and less than four involved axillary lymph nodes.     

Surgical adjuvant chemotherapy in non-small cell carcinoma of the lung

A review of the published clinical trials of surgical adjuvant chemotherapy in lung cancer indicated that in the majority of nonrandomized trials, conclusions favored the use of adjuvant chemotherapy. On the other hand, most randomized trials were unable to show any statistically significant difference in survival or disease-free interval between treated groups and controls. On the contrary, in several studies the survival was better in the control group. It was concluded that adjuvant chemotherapy has no place in the routine treatment of resectable lung cancer; however, further prospective controlled randomized trials are needed using new agents, new combinations, or new schedules.