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PubMed2002

The role of radical hysterectomy and neoadjuvant chemotherapy in carcinoma of the cervix.

The patient presenting with a bulky stage IB2 cervical cancer is a therapeutic challenge. None of the current surgical or radiation treatment strategies satisfactorily leads to a high rate of disease-free survival and a low risk of treatment-related complications including ovarian failure and psychosexual deficits. Neoadjuvant chemotherapy may allow for reductions in tumor bulk, thereby rendering radiation therapy more effective or surgery more feasible. Impressive clinical response rates to cisplatin-based neoadjuvant chemotherapy have been achieved with acceptable toxicity. Approximately 20% of patients achieve a complete clinical response, and many also experience a complete pathologic response. There are still too few comparative studies and phase III trials to assess the effectiveness of neoadjuvant chemotherapy and radical surgery relative to standard treatments.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed1990

Perioperative methotrexate, vinblastine, doxorubicin and cisplatin (M-VAC) for poor risk transitional cell carcinoma of the bladder: an Eastern Cooperative Oncology Group pilot study.

A total of 18 patients with locally advanced transitional cell carcinoma of the bladder underwent 2 preoperative cycles of chemotherapy with methotrexate, vinblastine, doxorubicin and cisplatin followed by radical cystectomy and 2 postoperative cycles of chemotherapy. Radical cystectomy was performed in 17 of 18 patients (94%) with a pathological partial response in 3 (17%) and a pathological complete response in 2 (11%), for an over-all response rate of 28% (95% confidence limits 10 to 53%). At 23-month median followup 9 patients (50%) remained without evidence of recurrent disease, while 9 (50%) died of metastatic bladder cancer. Average relative dose intensity of all therapy given was 78%. Hematological toxicity was moderate, with no septic deaths or bleeding complications. However, 4 thromboembolic events occurred. While downstaging of the primary bladder tumor can occur with this perioperative schedule our results were not as impressive as some previously reported findings. The incidence of thromboembolic events is worrisome.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed1999

Dose intensification of platinum compounds with glutathione protection as induction chemotherapy for advanced ovarian carcinoma.

Based on previous clinical experience indicating the tolerability and efficacy of high-dose cisplatin with glutathione protection in the treatment of advanced ovarian cancer, this study was undertaken to explore the efficacy and feasibility of an alternative high-dose, platinum-based approach including a combination of high-dose cisplatin plus carboplatin as induction chemotherapy of advanced ovarian carcinoma and intervention surgery. Fifty consecutive eligible patients with untreated stage III or IV epithelial ovarian cancer received 40 mg/m(2) cisplatin daily on days 1-4 and 160 mg/m(2) carboplatin on day 5. The cycle was repeated after 28 days. Patients received glutathione (2,500 mg) before each cisplatin or carboplatin administration and standard intravenous hydration. After 2 courses of induction chemotherapy, the patients underwent surgical reevaluation with debulking, when possible, followed by a further 3 cycles of 120 mg/m(2) cisplatin (i.e. 40 mg/m(2) daily for 3 consecutive days plus 600 mg/m(2) cyclophosphamide on day 3) except in instances of lack of response. All eligible patients were assessed for response and toxicity. The toxicity was moderate with lack of significant nephrotoxicity. Neurotoxicity and ototoxicity were acceptable and in no patient was treatment discontinued for those toxic effects. Myelotoxicity was somewhat more severe than that observed with our previous study with high-dose cisplatin and probably related to the addition of carboplatin. Of the 40 responsive patients, 23 (46%) had a pathological complete response and 4 (8%) had a clinical complete response (without second-look laparotomy). The efficacy of the present protocol was also documented by overall survival (median survival >48 months), which appeared to be better than expected with the current therapy in this group with advanced/bulky disease. The impressive efficacy suggests a possible contribution of reduced glutathione itself in improving the outcome, as supported by preclinical studies. The results of this study should be placed in context with current platinum-based therapy including paclitaxel.

Adult↗
PubMed2005

Neoadjuvant chemotherapy with cyclophosphamide, mitoxantrone, and 5-fluorouracil in locally advanced breast cancer.

OBJECTIVES: Our primary objective was to determine the response rate; secondary objectives were to assess the toxicity rate, and disease-free and overall survival rates in patients with locally advanced breast cancer (LABC) receiving a cyclophosphamide (500 mg/m2), mitoxantrone (12 mg/m2) and 5-fluorouracil (500 mg/m2) (CMF) chemotherapy regimen. PATIENTS AND METHODS: The data from 74 patients with LABC with neoadjuvant CMF chemotherapy were analyzed retrospectively. Preoperatively, all patients received 3 cycles of CMF on day 1, repeated every 21 days. In 3 (4.1%) patients, breast-conserving surgery was given and in 71 (95.9%) modified radical mastectomy. All patients received radiotherapy and 3 additional cycles of CMF chemotherapy after surgery. RESULTS: Median age of the patients was 47 years (range: 17-74). 43 patients were premenopausal, whereas 31 were postmenopausal. 54 patients were in stage IIIA, and 20 were in stage IIIB. The overall clinical response rate was 88%; 11 (14.9%) had a complete response, 54 (73%) had a partial response, and 2 (2.8%) had progression. 14 (18.9%) had a pathological complete response. The median follow-up was 62 months. The median disease-free survival was 64.9 months, and the median overall survival was 97.5 months. The 5-year disease-free and overall survival rates were 52% and 79.9%, respectively. Most frequent side-effects were nausea/vomiting, mucositis, alopecia and leukopenia. CONCLUSION: The CMF regimen has a high overall response rate and an acceptable side effect profile in the treatment of locally advanced breast cancer. Further studies are needed to evaluate its effectiveness in breast-conserving strategies.

Adolescent↗
PubMed2001

Comparative study of bulky stage IB and IA cervical cancer patients treated by radical hysterectomy with and without neoadjuvant chemotherapy: long-term follow-up.

One hundred and ninety patients with bulky (> 3 cm) stage IB and IIA cervical cancer who underwent radical hysterectomy between 1991 and 1994 at Maharaj Nakorn Chiang Mai Hospital were reviewed to determine whether neoadjuvant chemotherapy (NAC) with MVAC (Methotrexate, Vinblastine, Adriamycin, Cisplatin) improved survival. There were 42 patients treated with pre-operataive NAC (MVAC 1-3 courses) and 148 patients treated by primary surgery (PS). In the NAC group, the overall response rate from MVAC was 88.1 per cent with 31.0 per cent having complete clinical response and 7.1 per cent with complete pathological response. Pelvic lymph node metastasis was not significantly different between the NAC group (16.7%) and the PS group (18.2%). At a median follow-up of 64.5 months, 19.0 per cent in the NAC group and 18.2 per cent in the PS group had tumor recurrence. The 5-year progression free and overall survival was 80.8 per cent and 92.0 per cent respectively for the NAC group which was not significantly different from 80.2 per cent and 92.9 per cent respectively in the PS group. In conclusion, although NAC can decrease the tumor size and produce a high response rate, it does not improve survival in bulky stage IB and IIA cervical cancer patients.

Adenocarcinoma↗
PubMed1995

Cisplatin-based neoadjuvant chemotherapy for invasive bladder cancer.

Between February 1988 and March 1993, 24 patients with locally advanced bladder cancer (stages T2-4N0-3M0) were included in this study. Combination chemotherapy consisting of methotrexate, vinblastine, epirubicin (doxorubicin) and cisplatin (M-VAC) was given to the patients in a neoadjuvant setting. The clinical stage was T2N0M0 in eight patients, T3aN0M0 in three, T3bN0M0 in seven, T4N0M0 in five and T4N3M0 in one. After chemotherapy, total cystectomy was performed in 20 patients and partial cystectomy 4. Of 24 patients, one (4%) showed a pathological complete response, and eight (33%) had a pathological partial response, for an overall response rate of 38% (95% confidence limits 20 to 57%). Nine patients who achieved a pathological response to chemotherapy had a significantly higher survival rate than the nonresponders (p <0.01). In the relationship between the clinical stage and the response to chemotherapy, clinical T2 and T3a diseases were more likely to respond to chemotherapy than clinical T3b and T4 diseases, with a response rate of 64% and 15%, respectively. While a positive relationship between the pathological response and survival was observed, adequate follow-up is needed to assess the ability of neoadjuvant chemotherapy to improve the prognosis of patients with locally advanced bladder cancer.

Adult↗
PubMed2006

Response and cardiac toxicity of trastuzumab given in conjunction with weekly paclitaxel after doxorubicin/cyclophosphamide.

BACKGROUND: Adjuvant trastuzumab improves relapse-free survival in HER2-overexpressing breast cancer but is associated with cardiac toxicity. This phase II study was undertaken to determine the neoadjuvant clinical and pathologic response rate and the acute and chronic cardiac toxicity of trastuzumab given with weekly paclitaxel after AC (doxorubicin/cyclophosphamide). PATIENTS AND METHODS: Fifty-two women with newly diagnosed, stage II-IV, HER2-overexpressing breast cancer received AC for 4 cycles, followed by weekly TP (paclitaxel/trastuzumab) for 12 weeks, neoadjuvantly or adjuvantly, followed by 40 weeks of adjuvant trastuzumab. RESULTS: Congestive heart failure occurred in 4% of patients (95% confidence interval [CI], 0.5%-13.2%). Asymptomatic left ventricular ejection fraction (LVEF) decreases to < 50% occurred in 21% of patients (95% CI, 11.1%-34.7%); all but 1 recovered by 1.5 years. Median LVEF decreased progressively during therapy from 65% before therapy (95% CI, 63%-66%) to 62% after AC (95% CI, 59%-64%) and 58% after AC-TP (95% CI, 56%-64%; P < 0.01 for each decrease). The decrease in LVEF persisted 1.5 years after study entry at 57% (95% CI, 54%-60%), although all but 1 of the most severe decreases to < 50% recovered to normal. Clinical response rate among 37 patients treated neoadjuvantly was 86%, and the pathologic complete response rate was 19% (95% CI, 8%-35.2%). Because of withdrawals for toxicity, refractory disease, and patient preference, only 35% of patients completed the entire regimen. CONCLUSION: In this study, the AC-TP regimen resulted in a high clinical but moderate pathologic response rate, and although asymptomatic cardiac systolic dysfunction was common, most of the severe decreases recovered over time.

Adult↗
PubMed2005

Weekly docetaxel/carboplatin as primary systemic therapy for HER2-negative locally advanced breast cancer.

To evaluate the effectiveness and safety of weekly docetaxel/carboplatin as primary systemic therapy (PST) for locally advanced breast cancer, we conducted a phase II study. Forty-four patients with HER2-negative locally advanced or inflammatory breast cancer (IBC) received docetaxel 35 mg/m(2) and carboplatin to an area under the curve of 2 mg/mL/min for 3 of 4 weeks over 16 weeks. After completion of PST, patients had breast surgery and then received 4 cycles of adjuvant cyclophosphamide/doxorubicin, standard radiation therapy, and, for hormone receptorpositive tumors, tamoxifen. The mean tumor size was 9.3 cm (range, 5-24 cm). Thirty-seven patients (85%) had palpable lymph nodes; 13 patients (30%) had matted or fixed nodes (N2). Eight patients had IBC. There were 11 clinical complete responses (25%) and 29 clinical partial responses (66%), resulting in 40 objective responses (91% [95% CI, 78%-96%]). Invasive disease disappeared (pathologic complete response) from the breast and axilla in 6 patients (14% [95% CI, 5%-27%]) and from the axilla in 17 patients (39% [95% CI, 24%-55%]). The only significant adverse hematologic event was grade 3 neutropenia in 4 patients (9%). The most common adverse nonhematologic events were fatigue (84% of patients) and alopecia (84%), which were usually grade 1/2. Weekly docetaxel/carboplatin appears to be active and feasible as PST in patients with large breast tumors.

Adult↗
PubMed2006

Outcome of preoperative concurrent chemoradiotherapy and surgery for resectable lingual squamous cell carcinoma greater than 3 cm: the possibility of less extensive surgery.

We present the outcome of treatment with preoperative concurrent chemoradiotherapy and surgery for resectable lingual squamous cell carcinoma more than 3 cm in its greatest dimension. Twenty patients were enrolled in this study between June 2001 and August 2004. Concurrent chemoradiotherapy included intraarterial pirarubicin (THP) (5 mg/day), intravenous continuous 5-FU, and radiation, usually followed by surgery. Complete response rate was 100%. Notably, 8 of 12 patients who underwent surgery exhibited pathologically complete response, though three patients developed recurrence or distant metastasis. The main adverse effects were mucositis (13/20) and leucopenia (9/20), both of which were acceptable. Although long-term results should be considered, our treatment method appears very useful for lingual squamous cell carcinoma greater than 3 cm, with a remarkably high rate of pathological local control and acceptable adverse events.

Adult↗
PubMed1999

Prolonged neoadjuvant chemotherapy with GM-CSF in locally advanced breast cancer.

BACKGROUND: Neoadjuvant chemotherapy improves survival in patients with locally advanced breast cancer (LABC). Usually three to four cycles of conventional-dose neoadjuvant chemotherapy are administered prior to local therapy, and another three cycles thereafter. In an attempt to improve results, we increased the dosages and applied GM-CSF, which, besides being a hematopoietic growth factor, has become increasingly known for its immunostimulatory effects, which might enhance the antitumor effect. METHODS: Forty-two patients with stage IIIA or IIIB breast cancer were treated with doxorubicin (A) (90 mg/m2) and cyclophosphamide (C) (1,000 mg/m2) at three-weekly intervals. In the second and fourth cycle a 10% dose reduction of both agents was applied. On the second day GM-CSF 250 micrograms/m2/day was started and given for 10 days. Initially, some patients were treated with < or = four cycles, but as the study progressed and toxicity appeared tolerable, six cycles were given whenever possible. After the chemotherapy, patients underwent surgery and postoperative radiotherapy. RESULTS: The response rate for the whole group to AC was 98% (95% confidence interval 94%-100%), with a clinical complete response rate of 50% (95% confidence interval 35%-65%). Six patients had a pathological complete response. Median follow-up from the start of chemotherapy is 49 months (range 10-100). The disease-free survival (DFS) at three years is 57% and the overall survival (OS) at three years is 79%. There is a significant trend for improved DFS (p = 0.0000) and OS (p = 0.0002) with increasing number of cycles. CONCLUSION: The results of the present study with neoadjuvant dose-intensive AC chemotherapy and GM-CSF compare favorably with previous studies in patients with LABC. This is most apparent in patients who received six cycles of neoadjuvant chemotherapy. We hypothesize that these encouraging results are probably related to the prolonged presence of the primary tumor, and to the long-term administration of GM-CSF with the primary tumor and axillary lymph nodes in situ. Therefore, a randomized study is warranted. We already initiated an international randomized trial in patients with LABC in order to answer two questions. First, does prolonged neoadjuvant chemotherapy result in an improved DFS and OS in comparison with the conventional approach, and secondly, what is the effect of GM-CSF in this approach in comparison with G-CSF?

Adult↗
PubMed2005

Paclitaxel-based chemoradiotherapy in localized gastric carcinoma: degree of pathologic response and not clinical parameters dictated patient outcome.

PURPOSE: Preoperative chemoradiotherapy may increase the R0 (curative) resection rate, overall survival (OS) duration, and disease-free survival (DFS) duration. We evaluated paclitaxel-based induction chemotherapy and chemoradiotherapy in patients with localized gastric or gastroesophageal adenocarcinoma to determine its feasibility, impact on the R0 resection rate, type of pathologic response, OS, and DFS. PATIENTS AND METHODS: Patients with operable, localized gastric, or gastroesophageal adenocarcinoma were eligible. Staging included endoscopic ultrasonography (EUS) and laparoscopy. Patients received two 28-day cycles of induction chemotherapy of fluorouracil, paclitaxel, and cisplatin followed by 45 Gy of radiation and concurrent fluorouracil plus paclitaxel. The cancer was restaged and surgery was attempted. Postsurgery pathologic findings and R0 resection were correlated with OS and DFS. RESULTS: Forty-one patients were enrolled. Most carcinomas were proximal (83%) and pretreatment stage EUST3 (85%). Forty patients (98%) underwent surgery, and 78% had an R0 resection. We observed a pathologic complete response (pathCR) rate of 20% and a pathologic partial response (pathPR) rate of 15% (< 10% residual cancer cells in the resected specimen). No pretreatment parameter (sex, cancer location, baseline T stage, or baseline N stage) predicted the type of postsurgery pathologic response, OS, or DFS. However, pathCR (P = .02), pathCR + pathPR (P = .006), R0 resection (P < .001), and postsurgery T and N stages (P = .01 and P < .001, respectively) were associated with OS. Same parameters were significantly correlated with DFS. Toxicity was manageable. CONCLUSION: The type of pathologic response but not pretreatment parameters was associated with OS and DFS. Efforts to increase the rate of pathologic response and better systemic cancer control are warranted.

Adenocarcinoma↗
PubMed1997

Preoperative chemotherapy versus surgical therapy alone for squamous cell carcinoma of the esophagus: a prospective randomized trial.

OBJECTIVE: This study investigated the role of preoperative chemotherapy in squamous cell cancer of the esophagus. METHODS: A prospective randomized trial was undertaken in 147 patients: 74 received preoperative chemotherapy comprising cisplatin and 5-fluorouracil and 73 had surgical therapy alone. End points were cancer and therapy-related deaths. RESULTS: Sixty-six patients (89%) in the chemotherapy group underwent resection compared with 69 (95%) in the control group (p = not significant). Of the 60 patients who had resection after completing the chemotherapy program, 35 (58%) had a significant response, of whom four (6.7%) had a complete pathologic response. Postoperative mortality rates were 8.3% and 8.7% in the chemotherapy and control groups, respectively (p = not significant). Significant downstaging was evident with chemotherapy; curative resections were possible in 67% of these patients compared with 35% in the control group (p = 0.0003). T3 and T4 tumors were found in 67% and 91% of the chemotherapy and control groups, respectively (p = 0.0002). The respective figures for N1 disease were 70% and 88% (p = 0.009). An intent-to-treat analysis of survival showed no significant difference between the two groups. Median survivals were 16.8 and 13 months, respectively (p = 0.17). Of those who completed the chemotherapy and resection, responders fared better than control patients. Median survivals were 42.2 months and 13.8 months, respectively (p = 0.003). Median survival (8.3 months) was worse for nonresponders than for control patients (p = 0.03). The recurrence pattern suggested a significant reduction in locoregional disease with chemotherapy. CONCLUSIONS: Preoperative chemotherapy was safe and resulted in significant downstaging and an increased likelihood of curative resection. Survival was not better than that in the surgery-alone group, but responders did fare better than nonresponders.

Aged↗
PubMed2003

Is there still a role for neoadjuvant therapy in breast cancer?

The role of neoadjuvant chemotherapy in locally advanced breast cancer is firmly established. There is now also an emerging role for neoadjuvant systemic therapy in the treatment of operable breast cancer. There is good evidence that the chances of breast conserving surgery can be increased with this approach and results of randomised studies indicate that survival is at least as good with neoadjuvant as with adjuvant chemotherapy. Similar clinical data are emerging with neoadjuvant endocrine therapy. For the future, there are important potential advantages in having an in vivo measure of chemosensitivity rather than blindly treating micrometastatic disease in the adjuvant setting. Clinical response to neoadjuvant treatment, and in particular complete pathological response, are predictors of subsequent outcome. Pathological involvement of axillary nodes following neoadjuvant therapy portends a poor prognosis. The potential for biological surrogate markers of response to predict for long-term outcome may allow individualisation of systemic treatment and the rapid assessment of new drugs in early breast cancer.

Antineoplastic Agents, Hormonal↗
PubMed2004

High curative resection rate with weekly cisplatin, 5-fluorouracil, epidoxorubicin, 6S-leucovorin, glutathione, and filgastrim in patients with locally advanced, unresectable gastric cancer: a report from the Italian Group for the Study of Digestive Tract Cancer (GISCAD).

The aim of the present study was to evaluate the role of a weekly preoperative chemotherapy in locally advanced, unresectable gastric cancer. In all, 82 patients with an Eastern Oncology Cooperative Group PS <or=2 and normal cardiac function were enrolled onto the study. Surgical unresectability was confirmed in 52 patients (63%) at laparotomy, and in 30 (27%) cases by CT scan of the abdomen and endoscopic ultrasonography. Chemotherapy treatment was: cisplatin 40 mg x m(-2); 5-fluorouracil 500 mg x m(-2); epidoxorubicin 35 mg x m(-2); 6S-leucovorin 250 mg x m(-2) and glutathione 1.5 g x m(-2) (PELF). One cycle consisted of 8 weekly treatments. Response to chemotherapy was observed in 40 of 82 patients (49%): six (7%) complete and 34 (41%) partial responses, and in four (5%) cases a complete pathological response was confirmed. Of the 40 responding patients, 37 (45%) had potentially curative surgery. Grade 3/4 leucopenia and thrombocytopenia occurred in three and two patients. At a median follow-up of 48 months, 25 of the 37 resected patients (68%) were alive and 24 (65%) were disease free. The median and 4-year survival for the whole group was 17 months and 31%, respectively. The median survival was 12 months for inoperable patients and it was not reached in resected patients.

Adult↗
PubMed2003

Phase II trial combining docetaxel and doxorubicin as neoadjuvant chemotherapy in patients with operable breast cancer.

BACKGROUND: This study was conducted to assess the antitumour activity of docetaxel in combination with doxorubicin for neoadjuvant therapy of patients with breast cancer. PATIENTS AND METHODS: Forty-eight women were treated with intravenous doxorubicin 50 mg/m(2) over 15 min followed by a 1-h infusion of docetaxel 75 mg/m(2) every 3 weeks for six cycles. Dexamethasone or prednisolone premedication was allowed. Granulocyte colony-stimulating factor was not allowed as primary prophylaxis. The primary end point was the pathologically documented complete response rate (pathological response). RESULTS: The mean relative dose intensity calculated for four or more cycles was 0.99 for doxorubicin and 0.99 for docetaxel. Overall, the pathological response rate was 13%. There were 11 complete and 29 partial clinical responses for an overall response rate of 85% [95% confidence interval (CI) 75% to 95%] in the evaluable population (n = 47). Disease-free and overall survival rates were 85% (95% CI 71% to 94%) and 96% (95% CI 85% to 99%), respectively, after a median follow-up of 36.6 months. Grade 3/4 neutropenia was observed in 65% of patients and 17% reported grade 4 febrile neutropenia. CONCLUSIONS: Docetaxel and doxorubicin is an effective and well-tolerated combination in the neoadjuvant therapy of breast cancer. Future controlled trials are warranted to investigate the best schedules and to correlate response with biological factors.

Adult↗
PubMed2004

A phase II study of epirubicin, vinorelbine and cisplatin in advanced breast cancer.

Our objective was to evaluate the activity and safety of the combination of cisplatin, epirubicin and vinorelbine (CEV) in advanced breast cancer patients. Patients with advanced breast cancer, locally advanced or metastatic, received epirubicin 75 mg/m2 and cisplatin 50 mg/m2 on day 1, and vinorelbine 25 mg/m2 on day 8. Cycles were repeated every 3 weeks. A total of 35 patients were treated. Thirty-one patients were evaluated for response. One hundred and fifty-five cycles of chemotherapy were administered overall. The objective response rate (ORR) was 84%, including complete response in 13% of patients. All stage III patients achieved a downstaging, with a pathological complete response in two out of 10 patients. Patients with stage IV disease obtained objective response in 67% of cases. Toxicity was mild to moderate. The most common grade 3-4 adverse event was febrile neutropenia, which occurred in 17% of patients. We conclude that CEV combination represents an effective treatment for patients with previously untreated advanced breast cancer, allowing an important ORR. Moreover this regimen appears to be well tolerated.

Adolescent↗
PubMed1991

Chemotherapy (CAP) for the treatment of advanced ovarian cancer and second-effort surgery in the second look.

Seventy-two patients with advanced ovarian cancer received CAP chemotherapy followed by laparotomy and 'second-effort' surgery. The overall response to CAP therapy was 80%. A complete pathological response (CPR) was obtained in 16 patients and partial microscopic (PMiR) and macroscopic responses in 7 and 33 cases, respectively. The actuarial survival for the entire group was 36% at 50 months with a median survival of 34 months. No significant differences in survival between the CPR and PMiR groups were found. Radical second-effort surgery showed a somewhat beneficial effect. The tumor size before chemotherapy (less than 5 cm) and FIGO stage III had a significantly favorable effect on response rate and survival.

Adult↗
PubMed2002

Neoadjuvant chemotherapy with a combination of pegylated liposomal doxorubicin (Caelyx) and paclitaxel in locally advanced breast cancer: a phase II study by the Hellenic Cooperative Oncology Group.

BACKGROUND: To determine the activity and safety of the combination of paclitaxel and pegylated liposomal doxorubicin (Caelyx) in patients with locally advanced breast cancer. PATIENTS AND METHODS: This was a multicenter phase II study. Thirty-five newly diagnosed patients with locally advanced breast cancer were included in the study. Histological or cytological diagnosis was necessary for inclusion. Median age was 54 years (range 26-73 years). Fifteen patients were premenopausal and 20 postmenopausal. Paclitaxel was administered at a dose of 175 mg/m(2) and pegylated liposomal doxorubicin 35 mg/m(2) every 3 weeks for six cycles. RESULTS: Twenty-five patients (71%) responded. Six (17%) had a complete response, 19 (54%) had a partial response, four remained stable, two progressed and four were not evaluated for response due to discontinuation of chemotherapy. Three patients had a pathologically complete response. A total of 173 cycles were administered. The primary toxicity observed was skin toxicity. Grade 3 skin toxicity was noted in four patients (11%). Palmar-plantar erythrodysesthesia (PPE) grade 3 was experienced by three (9%). Two patients presented with PPE and skin toxicity. Hematological toxicities included grade 3 leukopenia in four patients (3%). Other grade 3 toxicities were uncommon and included only alopecia in 29 patients (83%). Grade 3 or 4 neurotoxicity was not observed in any patient. Dose reduction was necessary in seven patients; in six due to skin toxicity and in one due to neutropenia. Four patients discontinued treatment due to skin toxicity. There were no treatment-related deaths. CONCLUSIONS: The combination of pegylated liposomal doxorubicin and paclitaxel was active in locally advanced breast cancer. The primary toxicity was cutaneous toxicity and it was manageable.

Adult↗