Pathologic complete response (pCR) following weekly (wkly) paclitaxel (cremophor or albumin-bound) and carboplatin (TC) ± trastuzumab (H), ± bevacizumab (B) in patients (pts) with doxorubicin/cyclophosphamide-resistant (AC-Res) and AC-sensitive (AC-S) large and inflammatory breast cancer

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 591-591 ◽  
Author(s):  
R. S. Mehta ◽  
T. Schubbert ◽  
K. Kong ◽  
D. Hsiang ◽  
J. Butler ◽  
...  
Keyword(s):  
Pathologic Complete Response ◽  
Stage Iv ◽  
Complete Response ◽  
High Rate ◽  
Exact Test ◽  
Short Course ◽  
Resistance Reversal ◽  
Dose Dense

591 Introduction: Historically, pCR is rare in AC-Res in contrast to AC-S BC except following TCH in HER2+ BC in preliminary analysis (SABCS-2004, #1110). Moreover, robust predictors of pCR are needed. Methods: 106 consecutive BC pts on neoadjuvant studies were treated with GM/G-CSF supported dose-dense AC (except 7**- Table ), 2 cycles if AC-Res and 4 if AC-S. Pts then received 9–12 wkly TC (3 wks on, 1 off) ± 6–8 bi-wkly B if HER2- or +12–16 wkly H if HER2+, followed by surgery. Fisher’s exact test was performed to compare pCR percentages by various characteristics. Results: pCR in breast and lymph nodes in 38 of 84 assessable tumors in the first 82 pts were documented. 67% (56/84) tumors were reduced to ≤5 mm. Overall, no difference in pCR rates were found between AC-S and AC-Res BC, but pCR rates were 2- to 4-fold higher in HER2+, AC-S (79%) and AC-Res (65%) subsets compared to HER2-, AC-S (32%) and AC-Res (16%) subsets. Higher pCR rates were associated with HER2+/hormone receptor- (HR-) > HER2+/HR+, HER2-/HR- (triple-) > HER2-/HR+, and within the HER2+ subset-IHC 3+/FISH+ or unknown > IHC 3+/FISH- or IHC 1–2+/FISH+, and ductal > other histology. No patient had clinical cardiac dysfunction or EF <50, except 1 on AC/TC. 13/106 (12%) progression or death at a median follow-up of 22 months (range 2–46) is mostly due to stage IV and CNS progression. Conclusion: Short course of TCH achieves a high rate of pCR in AC-Res and AC-S, HER2+ BC in contrast to TC ± B in AC-Res and AC-S, HER2- BC. This is the first demonstration of high rate of complete AC resistance reversal across stage II-IV, inflammatory and recurrent HER2+ BC. In vivo response adjusted 2–4 cycles of dose-dense AC limited clinical cardiac toxicity. HER2+ (IHC 3+/FISH+ or unknown), HR- and ductal histology are significant predictors of high pCR. HER2 and HR confer 4 predictive subtypes of BC. [Table: see text] No significant financial relationships to disclose.

The Utility of Consolidative Upfront High Dose Chemoradiotherapy and ASCT in Patients with Mantle Cell Lymphoma (MCL).

Blood ◽  
2005 ◽  
Vol 106 (11) ◽  
pp. 2072-2072
Author(s):  
Daniel Persky ◽  
Carol S. Portlock ◽  
Simone Lessac-Chenen ◽  
Alexia Iasonos ◽  
Andrew D. Zelenetz ◽  
...  
Keyword(s):  
Bone Marrow Involvement ◽  
Conditioning Regimen ◽  
Stage Iv ◽  
Progression Free Survival ◽  
High Dose Chemotherapy ◽  
High Dose ◽  
Significant Difference ◽  
Dose Dense

Abstract Introduction: Two approaches to improve progression-free survival (PFS) in MCL are intensifying induction, as with hyperCVAD/M-A regimen, or intensifying consolidation with high dose chemoradiotherapy (HDT) and ASCT as in the prospective European MCL Network Trial. At MSKCC the strategy is to incorporate both approaches by administering an anthracycline-containing regimen in a dose dense fashion (CHOP- or R-CHOP-14) followed by consolidation with ICE (ifosfamide, carboplatin, etoposide) and HDT/ASCT. Patients: Forty six patients with newly diagnosed MCL underwent HDT/ASCT between 11/96 and 2/05. The median age was 55 years; 74% were male; 72% had bone marrow involvement, 39% had GI involvement, 7% were in leukemic phase, and 91% presented with stage IV disease. Splenomegaly was seen in 35%, B symptoms in 9%, KPS>70 in 93%, elevated LDH in 23%, and blastoid histology in 9%. Results: Induction was 4 to 6 cycles of CHOP-14 (43%), R-CHOP-14 (37%), or other doxorubicin-containing regimen (20%). Consolidation was performed with 2–3 cycles of ICE in 53% or R-ICE in 39%. Upfront treatment was well tolerated and permitted adequate stem cell collection and prompt transition to HDT/ASCT. Conditioning regimens were TBI/CY/VP-16 (59%) and BEAM (41%). Involved field radiation therapy was administered to 65%. Post-ASCT rituximab maintenance was given to 39%, with 57% of patients receiving rituximab as part of their treatment. Anthracycline-based induction led to CRu of 44% and ORR of 98%. Seventy two percent of patients were transplanted in CR, while the remaining 28% were in PR. At a median follow-up of 2.5 years (range 0.4–8.0 years) 17% of the patients have died and 24% have had progressive disease. The median OS and PFS have not been reached (lower 95% CI, 5.7 years and 4.4 years, respectively). The 5-year PFS and OS are 58% and 83%, respectively. The use of rituximab at any point during treatment prolonged PFS - only 1 of 26 patients receiving rituximab relapsed, as compared to 10 of 20 patients who were rituximab naive (p=0.03); thus far there is no significant difference in OS. There was no day 100 treatment related mortality. One patient developed bronchiolitis obliterans after ASCT and died of pulmonary fibrosis 6.5 years later; 3 patients have died of secondary cancers - one case each of MDS (1.6 years after ASCT), melanoma and lung cancer. Conclusion: These data provide evidence that dose-dense induction with CHOP-14 or R-CHOP-14 and consolidation with ICE/HDT/ASCT appears to be safe and effective, with minimal acute toxicity. Although the median follow-up is short, the use of rituximab appears to improve PFS. This contrasts with the findings of German LGLSG and may be a consequence of in vivo rituximab purging. Future therapy could incorporate all the successful elements of prior treatment programs, including R-CHOP-14, R-ICE, and radioimmunotherapy with high dose chemotherapy conditioning regimen, followed by ASCT and rituximab-based maintenance. PFS stratified by Rituximab PFS stratified by Rituximab

High complete response (CR) rate in patients (pts) with esophageal carcinoma (EC) undergoing neoadjuvant combination of docetaxel and cisplatin (DC) ± cetuximab(DCE) chemoradiation therapy—a retrospective analysis

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 15093-15093
Author(s):  
T. J. Fillos ◽  
P. Hentschel ◽  
K. Watkins ◽  
M. S. Karpeh ◽  
A. Meek ◽  
...  
Keyword(s):  
Objective Response ◽  
Pathologic Complete Response ◽  
Stage Iv ◽  
Complete Response ◽  
Neoadjuvant Chemoradiation ◽  
High Rate ◽  
Phase Iii ◽  
Weekly Docetaxel ◽  
Stage Iv Disease ◽  
Grade 3

15093 Background: EC is a highly lethal disease with 5 year survival less than 15%. Surgery offers a chance for cure in early disease. Still, fewer than 20% of pts treated with surgery alone are alive at 5 years. Neoadjuvant chemoradiation offers the theoretical advantage of increasing R0 resections and reducing early local and distal metastases which may translate into improved survival. Several clinical trials have resulted in pathologic complete response (pCR) rates of 20–30%. Methods: Newly diagnosed pts with EC Stage 2A (T3) to 4 received weekly Docetaxel (D)25–30mg/m2 and Cisplatin (C)25–30mg/m2.for 6–8 weeks concurrently with radiation, 5040 cGy in 28 fractions. Cetuximab (E) 200mg/m2 was added after it became accepted treatment in head and neck cancers. Pts were scheduled 4 - 6 weeks later for surgery followed by the same chemotherapy for total of 16 weeks of treatment. Pts were assessed for time to progression, overall survival and toxicities. Results: Fifteen pts treated in 2005–6 underwent IRB approved evaluation; 11 male and 4 female, median age of 62(range 44–78) . Four had squamous cell (SCC) and 11 adenocarcinomas. Nine pts had Stage II, 4 pts stage III and 2 pts stage IV disease. Seven pts underwent surgery, all R0 resections. Four of them had pCR, one pPR (downstaged from T3 to T1) and two pts had stable disease. An additional 3 pts had radiological and endoscopic proven CR (medically not surgical candidates) for an objective response (CR+PR) in 8 out of 15 pts (3 SCC and 5 adenoca). Five out of 9 receiving DC had an objective response while 3 of 6 receiving DCE responded. Five pts progressed prior to surgery. Grade 3/4 neutropenia occurred in 2, nausea in 3, and 1 pt experienced Grade 3 dehydration. Four patients required dose reductions by 20%. Six patients had one cycle and 2 had 3 cycles delayed by one week each. Conclusions: Neoadjuvant chemoradiation treatment with weekly Docetaxel and Cisplatin ± Cetuximab is tolerable with high rate of CRs. There was no observed difference in response with the addition of cetuximab. A Phase III study is suggested. No significant financial relationships to disclose.

Pathologic Complete Response Rates in Young Women With BRCA1-Positive Breast Cancers After Neoadjuvant Chemotherapy

2010 ◽  
Vol 28 (3) ◽  
pp. 375-379 ◽  
Author(s):  
Tomasz Byrski ◽  
Jacek Gronwald ◽  
Tomasz Huzarski ◽  
Ewa Grzybowska ◽  
Magdalena Budryk ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Neoadjuvant Chemotherapy ◽  
Brca1 Mutation ◽  
Pathologic Complete Response ◽  
Complete Response ◽  
High Rate ◽  
Breast Cancers ◽  
Mutation Carriers ◽  
Intermediate Rate

Purpose To estimate the rate of pathologic complete response (pCR) to neoadjuvant chemotherapy in BRCA1 mutation carriers according to chemotherapy regimen. Patients and Methods From a registry of 6,903 patients, we identified 102 women who carried a BRCA1 founder mutation and who had been treated for breast cancer with neoadjuvant chemotherapy. Pathologic complete response was evaluated using standard criteria. Results Twenty-four (24%) of the 102 BRCA1 mutation carriers experienced a pCR. The response rate varied widely with treatment: a pCR was observed in one (7%) of 14 women treated with cyclophosphamide, methotrexate, and fluorouracil (CMF); in two (8%) of 25 women treated with doxorubicin and docetaxel (AT); in 11 (22%) of 51 women treated with doxorubicin and cyclophosphamide (AC) or fluorouracil, doxorubicin, and cyclophosphamide (FAC), and in 10 (83%) of 12 women treated with cisplatin. Conclusion A low rate of pCR was observed in women with breast cancer and a BRCA1 mutation who were treated with AT or CMF. A high rate of pCR was seen after treatment with cisplatin. An intermediate rate of PCR was associated with AC or FAC. The relative benefits of AC and platinum therapy need to be confirmed through follow-up of this and other cohorts.

The effect on pCR of bevacizumab and/or antimetabolites added to standard neoadjuvant chemotherapy: NSABP protocol B-40.

2011 ◽  
Vol 29 (18_suppl) ◽  
pp. LBA1005-LBA1005 ◽  
Author(s):  
H. D. Bear ◽  
G. Tang ◽  
P. Rastogi ◽  
C. E. Geyer ◽  
A. Robidoux ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Neoadjuvant Chemotherapy ◽  
Pathologic Complete Response ◽  
Metastatic Breast ◽  
Complete Response ◽  
Test Statistic ◽  
Exact Test ◽  
Poorly Differentiated

LBA1005 Background: The addition of capecitabine (X), gemcitabine (G), and bevacizumab (B) to taxanes have each improved PFS in metastatic breast cancer. The primary aims of this trial were to determine if adding X or G to docetaxel (T) → AC will increase breast pathologic complete response (pCR) rates in operable, HER2-negative breast cancer and if adding B to T-based regimens →AC will increase pCR rates. Secondary aims included assessment of clinical complete response (cCR) rates. Methods: Pts received one of 3 T-based regimens, with or without B, 15mg/kg, q3wks x 4: T 100 mg/m2 day 1; T 75 mg/m2 day 1 and X 825 mg/m2 BID days 1-14; or T 75 mg/m2 day 1 and G 1000 mg/m2 days 1 and 8. Pts then received preoperative AC x 4, with or without B for the initial 2 cycles of AC. Pts randomized to B resumed B for 10 postop doses. The primary endpoint was pCR in the breast. The maximum of the standardized pairwise differences between pCR rate for the T → AC regimen and for the other 2 T-based regimens was used as the test statistic to adjust for multiple comparisons. Fisher’s exact test was used to compare the arms with and without B. Results: The groups were balanced, with 47% clinically node+, 56% poorly differentiated, and 59% HR+. Assessments for pCR were available from 1180 of 1206 randomized patients. pCR for TX and TG were 29.7% and 32% vs. 32.7% for T. Neither TX nor TG increased cCR rates relative to T (58.3% and 60.4% vs. 61.5%). TX and TG increased toxicity. Addition of B increased the pCR rate (28.4 vs. 34.5%, p=0.027) and the cCR rate (55.8 vs. 64.3%, p=0.007). The effect of B was predominantly in the HR+ subset (15.2 vs. 23.3%, p=0.008) with minimal effect in the HR- subset (47.3% vs. 51.3%, p=0.44). Grades 2/3/4 toxicities increased with B were HTN (1/<1/0% vs. 13/9/<1%), HFS (11/7/0% vs. 15/11/0%), and mucositis (10/3/0% vs. 20/5/0%). Conclusions: The addition of B to neoadjuvant chemotherapy improved pCR and cCR rates, but the addition of X or G to T did not improve outcomes. Follow-up for wound healing issues and DFS will help define the role of B in the treatment of early breast cancer. Funded by NCI PHS grants U10-CA-37377, U10-CA-69974, U10-CA-12027, U10-CA-69651, and U10-CA-44066, and F. Hoffmann La-Roche, Ltd., Genentech, USA, and Eli Lilly.

Neoadjuvant gemcitabine-cisplatin (GC) for muscle-invasive bladder cancer (MIBC): Does midway CT staging predict for pathologic complete response (pCR)?

2014 ◽  
Vol 32 (4_suppl) ◽  
pp. 306-306
Author(s):  
Jo-An Seah ◽  
Raya Leibowitz-Amit ◽  
Eshetu G. Atenafu ◽  
Nimira Alimohamed ◽  
Anthony Michael Joshua ◽  
...  
Keyword(s):  
Bladder Tumour ◽  
Pathologic Complete Response ◽  
Complete Response ◽  
Exact Test ◽  
Disease Characteristics ◽  
Definitive Therapy ◽  
Radiological Response ◽  
Muscle Invasive ◽  
To Receive

306 Background: Neoadjuvant cisplatin-based chemotherapy (NC) improves overall survival in MIBC, with pCR post radical cystectomy (RC) linked to better outcomes. NC is underutilized in part due to concerns over disease progression during NC. Midway radiological CT (post 2 NC cycles) may identify patients (pts) progressing on NC who should proceed to definitive therapy (DT). Methods: We reviewed 39 MIBC pts planned to receive 4 cycles of NC (GC) between Jan2005-April2013. Most pts (70%) had midway CT staging. A radiological response was defined as clear improvement in tumour +/- nodal status on CT compared to baseline, taking into account prior trans-urethral resection of bladder tumour; any other result was considered no response. DT consisted of RC, concurrent chemoradiation (CCR), or radiation alone (R). Descriptive statistics and Fisher’s exact test examined associations between disease characteristics and outcomes. Results: Overall, 28 pts (72%) completed planned NC; 7 pts (18%) stopped early due to no response on midway CT; 4 (10%) discontinued due to death (1), sepsis (2), and fatigue (1). Twenty-six pts (67%) had RC, 3 (8%) had CCR, 6 (15 %) had R and 4 (10%) did not receive DT. Of the 26 RC pts – 6 (23%) had a pCR. There were no pCRs among pts who had no radiological response at midway CT. At time of last follow up, 8 pts (21%) had died, 13 (33%) had recurrence/ metastases, and the remainder are being actively followed. Of pts with pCR, there were no recurrences (median follow up 12.2 mo (range 6.3-20.9 mos). The rate of venothromboembolism (VTE) was 26%, and nearly half occurred during NC, but did not affect treatment. Conclusions: Lack of response on midway CT was associated with a lack of pCR at RC, suggesting midway staging may be of value in MIBC receiving NC. The rates of pCR were consistent with reported literature, but rates of VTE appear higher than expected and requires further investigation. [Table: see text]

scholarly journals Durable Long-Term Remission With Chemotherapy Alone for Stage II to IV Laryngeal Cancer

2009 ◽  
Vol 27 (12) ◽  
pp. 1976-1982 ◽  
Author(s):  
F. Christopher Holsinger ◽  
Merrill S. Kies ◽  
Eduardo M. Diaz ◽  
Ann M. Gillenwater ◽  
Jan S. Lewin ◽  
...  
Keyword(s):  
Laryngeal Cancer ◽  
Pathologic Complete Response ◽  
Complete Response ◽  
Concurrent Chemotherapy ◽  
Stage Ii ◽  
High Rate ◽  
Disease Remission ◽  
Laryngeal Surgery ◽  
Platinum Based Chemotherapy

Purpose For patients with stage II to IV laryngeal cancer, radiation therapy (RT) either alone or with concurrent chemotherapy provides the highest rate of organ preservation but can be associated with functional impairment. Thus, we studied the use of induction chemotherapy with or without conservation laryngeal surgery (CLS). Our objectives were to study the sensitivity of laryngeal cancer to platinum-based chemotherapy alone and to highlight the efficacy of CLS in this setting. Patients and Methods Thirty-one previously untreated patients with laryngeal cancer (T2-4, N0-1, M0), who were resectable with CLS, were enrolled. Patients received three to four cycles of paclitaxel, ifosfamide, and cisplatin (TIP) chemotherapy, and response was assessed histologically. Patients with partial response (PR) proceeded to CLS. Patients achieving pathologic complete response (pCR) received an additional three cycles of TIP and no other treatment. Results Thirty patients were assessable for response. With TIP chemotherapy alone, 11 patients (37%) achieved pCR, 10 of whom (33%) remain alive with durable disease remission and no evidence of recurrence over a median follow-up time of 5 years. Nineteen patients (63%) treated with TIP alone achieved PR. The overall laryngeal preservation (LP) rate was 83%, and only five patients (16%) required postoperative RT. No patient required a gastrostomy tube or tracheotomy. Conclusion Chemotherapy alone in selected patients with T2-4, N0-1 laryngeal cancer can provide durable disease remission at 5 years. For patients with PR, CLS provides a high rate of LP. This prospective study suggests that chemotherapy alone may cure selected patients with laryngeal cancer, warranting further prospective investigation.

Long-Term Results of Combined-Modality Therapy in Resectable Non–Small-Cell Lung Cancer

2002 ◽  
Vol 20 (8) ◽  
pp. 1989-1995 ◽  
Author(s):  
Jocelyne Martin ◽  
Robert J. Ginsberg ◽  
Ennapadam S. Venkatraman ◽  
Manjit S. Bains ◽  
Robert J. Downey ◽  
...  
Keyword(s):  
Combined Modality Therapy ◽  
Pathologic Complete Response ◽  
Complete Response ◽  
Complete Resection ◽  
Small Cell ◽  
Long Term Results ◽  
Small Cell Lung ◽  
Combined Modality

PURPOSE: Assessment of long-term results of combined-modality therapy for resectable non–small-cell lung cancer is hampered by insufficient follow-up and small patient numbers. To evaluate this, we reviewed our collective experience. PATIENTS AND METHODS: This study was a retrospective chart review recording demographics, tumor stage, treatment, and outcome of consecutive patients undergoing surgery. Survival was analyzed by Kaplan-Meier, and prognostic factors were analyzed by log-rank and Cox regression. RESULTS: From January 1993 to December 1999, 470 patients were treated, with follow-up in 446: 27 stage I, 55 stage II, 316 stage III, 43 stage IV (solitary M1), and five uncertain. Chemotherapy was mitomycin/vinblastine/cisplatin (174 patients [39.0%]), carboplatin/paclitaxel (148 [33.2%]), and other combination (124 [27.8%]); 75 patients (16.8%) received induction radiation. Resection was complete in 77.4%, incomplete in 8.3%, attempted but with gross residual disease afterward in 1.8%, and not performed in 12.6%. Pathologic complete response occurred in 20 patients (4.5%). With median follow-up of 31.0 months for patients still alive, median and 3-year survival for pathologic stages 0, I, II, III, and IV were more than 90 months, 73%; 42 months, 52%; 23 months, 35%; 16 months, 28%; and 16 months, 23% (P < .001). In a multivariate analysis, age, complete resection, pathologic stage, and pneumonectomy, but not induction regimen, significantly influenced survival. CONCLUSION: Although pathologic complete response outside the protocol setting is low, survival of this large patient cohort is comparable to that of patients in published combined-modality trials. Survival is significantly influenced by patient age, complete resection, pathologic stage, and pneumonectomy. These results can help guide standard clinical practice and emphasize the need for novel induction regimens.

Treatment of mild-to-moderate pelvic inflammatory disease with a short-course azithromycin-based regimen versus ofloxacin plus metronidazole: results of a multicentre, randomised controlled trial

2020 ◽  
pp. sextrans-2020-054468
Author(s):  
Gillian Dean ◽  
Suneeta Soni ◽  
Rachel Pitt ◽  
Jonathan Ross ◽  
Caroline Sabin ◽  
...  
Keyword(s):  
Antimicrobial Resistance ◽  
Pelvic Inflammatory Disease ◽  
Inflammatory Disease ◽  
Clinical Cure ◽  
Primary Outcome ◽  
Controlled Trial ◽  
High Rate ◽  
Resistance Testing ◽  
Short Course

ObjectiveA multicentre, randomised non-inferiority trial compared the efficacy and safety of 14 days of ofloxacin and metronidazole (standard-of-care (SoC)) versus a single dose of intramuscular ceftriaxone followed by 5 days of azithromycin and metronidazole (intervention arm (IA)) in women with mild-to-moderate pelvic inflammatory disease (PID).MethodsWomen with a clinical diagnosis of PID presenting at sexual health services were randomised to the SoC or IA arms. Treating clinicians and participants were not blinded to treatment allocation but the clinician performing the assessment of primary outcome was blinded. The primary outcome was clinical cure defined as ≥70% reduction in the modified McCormack pain score at day 14–21 after starting treatment. Secondary outcomes included adherence, tolerability and microbiological cure.ResultsOf the randomised population 72/153 (47.1%) reached the primary end point in the SoC arm, compared with 68/160 (42.5%) in the IA (difference in cure 4.6% (95% CI −15.6% to 6.5%). Following exclusion of 86 women who were lost to follow-up, attended outside the day 14–21 follow-up period, or withdrew consent, 72/107 (67.3%) had clinical cure in the SoC arm compared with 68/120 (56.7%) in the IA, giving a difference in cure rate of 10.6% (95% CI −23.2% to 1.9%). We were unable to demonstrate non-inferiority of the IA compared with SoC arm. Women in the IA took more treatment doses compared with the SoC group (113/124 (91%) vs 75/117 (64%), p=0.0001), but were more likely to experience diarrhoea (61% vs 24%, p<0.0001). Of 288 samples available for analysis, Mycoplasma genitalium was identified in 10% (28/288), 58% (11/19) of which had baseline antimicrobial resistance-associated mutations.ConclusionA short-course azithromycin-based regimen is likely to be less effective than the standard treatment with ofloxacin plus metronidazole. The high rate of baseline antimicrobial resistance supports resistance testing in those with M. genitalium infection to guide appropriate therapy.Trial registration number2010-023254-36.

Frequency, Clinicopathologic Characteristics, and Follow-up of HER2-Positive Nonpleomorphic Invasive Lobular Carcinoma of the Breast

2019 ◽  
Vol 153 (5) ◽  
pp. 583-592 ◽  
Author(s):  
Huina Zhang ◽  
Ioana Moisini ◽  
Rana M Ajabnoor ◽  
Bradley M Turner ◽  
Marcus D’aguiar ◽  
...  
Keyword(s):  
Invasive Lobular Carcinoma ◽  
Lobular Carcinoma ◽  
Pathologic Complete Response ◽  
Growth Factor Receptor ◽  
Complete Response ◽  
Her2 Positive ◽  
Clinicopathologic Characteristics ◽  
Study Population ◽  
Her2 Positivity

Abstract Objectives To investigate human epidermal growth factor receptor 2 (HER2)-positive nonpleomorphic invasive lobular carcinoma (ILC), which has rarely been addressed. Methods Clinicopathologic characteristics and follow-up of HER2-positive nonpleomorphic ILCs were collected and compared to those of HER2-negative counterparts. Results Twenty-one cases of HER2-positive nonpleomorphic ILCs were identified, 6.3% of the study population. Compared to HER2-negative nonpleomorphic ILC, patients with HER2 positivity were older (P &lt; .05), likely to be hormonal receptor negative (P &lt; .01), and had higher histologic grade and angiolymphatic invasion (P &lt; .01). HER2 positivity in nonpleomorphic ILCs was associated with higher recurrence/metastasis with hazard ratio of 2.03 (P &lt; .05). No patient who received neoadjuvant therapy achieved pathologic complete response, and HER2-targeted therapy tended to reduce recurrence/metastasis in patients with HER2-positive nonpleomorphic ILC. Conclusions Our results highlight the existence of HER2 positivity in nonpleomorphic ILCs and reinforce that HER2 is associated with worse prognosis in nonpleomorphic ILC.

scholarly journals Impact of the Addition of Carboplatin and/or Bevacizumab to Neoadjuvant Once-per-Week Paclitaxel Followed by Dose-Dense Doxorubicin and Cyclophosphamide on Pathologic Complete Response Rates in Stage II to III Triple-Negative Breast Cancer: CALGB 40603 (Alliance)

2015 ◽  
Vol 33 (1) ◽  
pp. 13-21 ◽  
Author(s):  
William M. Sikov ◽  
Donald A. Berry ◽  
Charles M. Perou ◽  
Baljit Singh ◽  
Constance T. Cirrincione ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Triple Negative Breast Cancer ◽  
Triple Negative ◽  
Pathologic Complete Response ◽  
Complete Response ◽  
Stage Ii ◽  
Open Label ◽  
Grade 3 ◽  
Dose Dense ◽  
The Impact

Purpose One third of patients with triple-negative breast cancer (TNBC) achieve pathologic complete response (pCR) with standard neoadjuvant chemotherapy (NACT). CALGB 40603 (Alliance), a 2 × 2 factorial, open-label, randomized phase II trial, evaluated the impact of adding carboplatin and/or bevacizumab. Patients and Methods Patients (N = 443) with stage II to III TNBC received paclitaxel 80 mg/m2 once per week (wP) for 12 weeks, followed by doxorubicin plus cyclophosphamide once every 2 weeks (ddAC) for four cycles, and were randomly assigned to concurrent carboplatin (area under curve 6) once every 3 weeks for four cycles and/or bevacizumab 10 mg/kg once every 2 weeks for nine cycles. Effects of adding these agents on pCR breast (ypT0/is), pCR breast/axilla (ypT0/isN0), treatment delivery, and toxicities were analyzed. Results Patients assigned to either carboplatin or bevacizumab were less likely to complete wP and ddAC without skipped doses, dose modification, or early discontinuation resulting from toxicity. Grade ≥ 3 neutropenia and thrombocytopenia were more common with carboplatin, as were hypertension, infection, thromboembolic events, bleeding, and postoperative complications with bevacizumab. Employing one-sided P values, addition of either carboplatin (60% v 44%; P = .0018) or bevacizumab (59% v 48%; P = .0089) significantly increased pCR breast, whereas only carboplatin (54% v 41%; P = .0029) significantly raised pCR breast/axilla. More-than-additive interactions between the two agents could not be demonstrated. Conclusion In stage II to III TNBC, addition of either carboplatin or bevacizumab to NACT increased pCR rates, but whether this will improve relapse-free or overall survival is unknown. Given results from recently reported adjuvant trials, further investigation of bevacizumab in this setting is unlikely, but the role of carboplatin could be evaluated in definitive studies, ideally limited to biologically defined patient subsets most likely to benefit from this agent.

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