Adjuvant chemotherapy in stage IB non-small cell lung cancer (NSCLC): Update of Cancer and Leukemia Group B (CALGB) protocol 9633

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 7007-7007 ◽  
Author(s):  
G. M. Strauss ◽  
J. E. Herndon ◽  
M. A. Maddaus ◽  
D. W. Johnstone ◽  
E. A. Johnson ◽  
...  
Keyword(s):  
Adjuvant Chemotherapy ◽  
Final Analysis ◽  
P Value ◽  
Logrank Test ◽  
Stage Ib ◽  
Accrual Rate ◽  
Clinically Significant ◽  
Resected Stage ◽  
Group B

7007 Background: In 2004, preliminary results of CALGB 9633 demonstrated statistically significant evidence that adjuvant chemotherapy with paclitaxel and carboplatin (PC) improved disease-free (DFS) and overall survival (OS) in resected stage IB NSCLC. Indeed, the study was closed early by the DSMB after a planned interim analysis demonstrated a p value for OS less than a prespecified stopping boundary. However, two larger trials, NCIC-JBR10 and ANITA, have shown significant OS advantages with adjuvant chemo, but failed to demonstrate improved survival in the stage IB subset. This report provides more mature data from CALGB 9633. Methods: InCALGB 9633, stage IB patients (pts) were randomized following resection to paclitaxel 200 mg/m2 and carboplatin AUC 6 q3wks ×4 cycles or to observation. While initially planned to accrue 500 pts, the accrual rate was <50% of expected. Because slow accrual allowed longer observation times for each pt, the accrual target was reduced to 384 pts. OS is the primary endpoint. The redesigned study had 80% power to detect a hazard ratio (HR) of 0.67 after 150 observed deaths using a 1-tailed logrank test conducted at the 0.05 level of significance. Results: Between 9/15/96 and 11/26/03, 344 pts were randomized. Median follow-up is 54 mo. Demographics and toxicity has been previously reported (JCO Sup, 22:621a, 2004). The current intent-to-treat analysis shows a significant improvement in DFS favoring adjuvant chemo (HR=0.74; 90% 2-sided CI: 0.57–0.96; p=0.027). There is a trend toward improvement in OS that is not significant (HR=0.80; 90% CI: 0.60–1.07; p=0.10). There is, however, a significant advantage in 3-yr survival (79% vs. 70%; p=0.045). Five-yr survival is not different (60% vs. 57%; p=0.32), although median follow-up is <5 yrs and CIs are wide. Continued follow-up is planned since only 131 of 150 deaths required for final analysis have been observed. Conclusions: This updated but “preliminary” analysis no longer shows a significant OS advantage for adjuvant chemotherapy in stage IB NSCLC. However, the re-designed study does not have adequate power to detect small differences in OS that may be clinically significant. Advantages in DFS and 3-yr survival support continued consideration of adjuvant PC in stage IB NSCLC. [Table: see text]

CLINICO-PATHOLOGICAL AND RADIOLOGICAL PROGNOSTIC FACTORS IN CANCER CERVIX TREATED WITH CONCURRENT CHEMORADIATION

2016 ◽  
Vol 1 (1) ◽  
Author(s):  
Manraj S. Kang ◽  
Kamal Sahni ◽  
Piyush Kumar ◽  
Rajneesh Madhok ◽  
Ratna Saxena ◽  
...  
Keyword(s):  
Prognostic Factors ◽  
Mitotic Index ◽  
Univariate Analysis ◽  
Disease Free Survival ◽  
Concurrent Chemoradiation ◽  
P Value ◽  
Publication Date ◽  
Cancer Cervix ◽  
Stage Ib

<bold>Introduction:</bold> Cervical cancer is most common cancer in the rural and second most common in urban areas of our country. It accounts for 16% of all cancers. There are various clinical, Paper Submission Datepathological and radiological factors which dictate the prognosis of these cancer cervix patients. The present study evaluates clinical, pathological and radiological prognostic factors in cancer cervix treated with concurrent chemoradiation. <bold>Material and Methods:</bold> A total of 32 patients seen between 2012 and 2014 patients planned concurrent chemoradiation were evaluated in terms of clinical (age, stage, Hb% and HPV Paper Publication Date infection), pathological (histopathology type and subtype, grade, mitotic index, lymph-July 2016 vascular invasion and necrosis) and radiological (parametrial extension, disease dimension, lymph node, hydronephrosis and vascularity of tumour) prognostic factors. After pre-DOI treatment evaluation patient was planned for 3 Dimentional-Conformal Radiotherapy (50Gy/25#/5 weeks) with concurrent chemotherapy (Cisplatin 35mg/m<sup>2</sup>) followed by 3 applications of Intracavitary radiotherapy (6Gy/fraction) with 6 months follow up. Response was accessed according to WHO response criteria and univariate analysis was done using chi-square test. <bold>Results:</bold> Clinical factors: Age – better disease free survival in older patients (p value=0.003), stage - Lower stage had better survival (for stage Ib-IIa vs stage IIb p value = 0.003 and for stage Ib vs. IIIb p value = 0.0005), Hb% - 57% patients with Hb <10g/dl had recurrence at end of 6 months (p value=0.00001), HPV – High recurrence with HPV presence. Pathological factors like high Mitotic Index had more residual disease (p=0.0009), grade - No statistical significance. Radiological factors- volume of disease - 35 % patients with volume of disease > 6 cm had disease at end of 6 months, hydronephrosis - 40 % patient with hydronephrosis had recurrence (p value = 0.0005) at end of 6 months follow up and vascularity of tumour showed statistically no difference. <bold>Conclusion:</bold> Hb <10%, HPV infection, Mitotic index (3-5/HPF), stage IIIB, pelvic nodes were concluded as the independent poor prognostic factors.

scholarly journals 465 No Role for Postoperative Antibiotics in Uncomplicated Appendicitis

2021 ◽  
Vol 108 (Supplement_2) ◽  
Author(s):  
N Ayoub ◽  
Y Tryliskyy ◽  
M K Baig
Keyword(s):  
Wound Infection ◽  
P Value ◽  
Nice Guidelines ◽  
Uncomplicated Appendicitis ◽  
Perforated Appendix ◽  
Group A ◽  
Preoperative Antibiotics ◽  
Group B ◽  
Variable Practice

Abstract Introduction Several studies have shown benefit from use of preoperative antibiotics in reducing postoperative infection after appendectomy as well as efficacy of postoperative antibiotics in complicated appendicitis (defined as perforated appendix or presence of pus in peritoneum). While for uncomplicated appendicitis, several studies showed no benefit from antibiotics postoperatively but there are no clear NICE guidelines till now and so surgeons have different practice based on their preferences. Method This study included patients who had appendectomy for uncomplicated appendicitis in Worthing hospital from 1st July 2019 till 30th June 2020. The end point was 30-day follow up postoperatively for wound infection or collection. Results 90 patients were admitted with uncomplicated appendicitis with age 6-80 years (mean of 31.3). 46 patients (51%) did not receive postoperative antibiotics (group A) and 44 (49%) received postoperative antibiotics (group B) with a variable practice from one dose to 8-day course. postoperatively, only 1 patient (2.1%) in group A developed wound infection requiring drainage while none in group B developed complications (p-value=1). Conclusions Administration of postoperative antibiotics in uncomplicated appendicitis showed no superiority over non-administration. in addition, they add extra cost on NHS. So, their routine use postoperatively is not recommended, however, larger studies are required to confirm this.

scholarly journals Sequential Versus Concurrent Trastuzumab in Adjuvant Chemotherapy for Breast Cancer

2011 ◽  
Vol 29 (34) ◽  
pp. 4491-4497 ◽  
Author(s):  
Edith A. Perez ◽  
Vera J. Suman ◽  
Nancy E. Davidson ◽  
Julie R. Gralow ◽  
Peter A. Kaufman ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Adjuvant Chemotherapy ◽  
Growth Factor Receptor ◽  
Disease Free Survival ◽  
Standard Of Care ◽  
Phase Iii ◽  
P Value ◽  
Sequential Administration ◽  
Taxane Chemotherapy

Purpose NCCTG (North Central Cancer Treatment Group) N9831 is the only randomized phase III trial evaluating trastuzumab added sequentially or used concurrently with chemotherapy in resected stages I to III invasive human epidermal growth factor receptor 2–positive breast cancer. Patients and Methods Patients received doxorubicin and cyclophosphamide every 3 weeks for four cycles, followed by paclitaxel weekly for 12 weeks (arm A), paclitaxel plus sequential trastuzumab weekly for 52 weeks (arm B), or paclitaxel plus concurrent trastuzumab for 12 weeks followed by trastuzumab for 40 weeks (arm C). The primary end point was disease-free survival (DFS). Results Comparison of arm A (n = 1,087) and arm B (n = 1,097), with 6-year median follow-up and 390 events, revealed 5-year DFS rates of 71.8% and 80.1%, respectively. DFS was significantly increased with trastuzumab added sequentially to paclitaxel (log-rank P < .001; arm B/arm A hazard ratio [HR], 0.69; 95% CI, 0.57 to 0.85). Comparison of arm B (n = 954) and arm C (n = 949), with 6-year median follow-up and 313 events, revealed 5-year DFS rates of 80.1% and 84.4%, respectively. There was an increase in DFS with concurrent trastuzumab and paclitaxel relative to sequential administration (arm C/arm B HR, 0.77; 99.9% CI, 0.53 to 1.11), but the P value (.02) did not cross the prespecified O'Brien-Fleming boundary (.00116) for the interim analysis. Conclusion DFS was significantly improved with 52 weeks of trastuzumab added to adjuvant chemotherapy. On the basis of a positive risk-benefit ratio, we recommend that trastuzumab be incorporated into a concurrent regimen with taxane chemotherapy as an important standard-of-care treatment alternative to a sequential regimen.

scholarly journals Comparable Efficacy of Terbinafine and Itraconazole in the Treatment of Tinea Pedis

2013 ◽  
Vol 21 (2) ◽  
pp. 74-79
Author(s):  
Md Abdul Wahab ◽  
Mohammad Jamal Uddin ◽  
Biswas Shahen Hassan ◽  
Md Zafrul Islam ◽  
Ishrat Bhuiyan ◽  
...  
Keyword(s):  
Fungal Infection ◽  
Tinea Pedis ◽  
Comparable Efficacy ◽  
P Value ◽  
Mycological Cure ◽  
Efficacy Analysis ◽  
Group A ◽  
Group B

Background: Tinea pedis (athlet’s foot) is the most common fungal infection. Relapse is common in tinea pedis and may be result of recurrence following inadequate treatment or reinfection. Objective: To evaluate the comparable efficacy of terbinafine and itraconazole in the treatment of tinea pedis. Methods: 120 patients of tinea pedis confirmed by KOH microscopy were included in the study. The study was carried out in three different Hospitals and Private Chambers for a period of 3 years from July 2006 to June 2009. Mean age of the patients was 40.28±10.23. The patients were devided into 2 equal group:A & B. Group- A was given terbinafine 250 mg/day and group-B was given intraconazole 200 mg/day for 2 weeks. Results: Follow up 2 weeks after cessation of therapy revealed clinical and mycological cure of 93.3% in terbinafine group and 86.6% in itraconazole group. Conclusion: Efficacy analysis revealed that terbinafine is superior than itraconazole in the treatment of tinea pedis (P value 0.224). DOI: http://dx.doi.org/10.3329/bjmed.v21i2.13615 Bangladesh J Medicine 2010; 21: 74-79

scholarly journals P1.05-014 Efficacy of Adjuvant Chemotherapy for Completely Resected Stage IB Non-Small Cell Lung Cancer

2017 ◽  
Vol 12 (11) ◽  
pp. S1983
Author(s):  
M.K. Byun ◽  
H.J. Park ◽  
H.S. Park ◽  
H. Jeung ◽  
J.Y. Cho ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Adjuvant Chemotherapy ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Small Cell ◽  
Small Cell Lung ◽  
Stage Ib ◽  
Resected Stage

T-cell clonality in peripheral blood as a predictor of progression to systemic treatment in patients with stage IB mycosis fungoides (MF).

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e19538-e19538
Author(s):  
Suravi Raychaudhuri ◽  
Charli-Joseph Yann ◽  
Michelle Mintz ◽  
Laura Pincus ◽  
Chiung-Yu Huang ◽  
...  
Keyword(s):  
T Cell ◽  
Peripheral Blood ◽  
Systemic Treatment ◽  
Rank Test ◽  
P Value ◽  
Advanced Stage ◽  
Stage Ib ◽  
Log Rank Test ◽  
Secondary Outcomes

e19538 Background: A major unmet clinical need in the care of early-stage MF patients is the identification of those with a high risk of failing skin directed therapy or progressing to advanced disease. Herein, we inquired if the identification of a clonal T-cell receptor (TCR) gene rearrangement by PCR in peripheral blood could predict the clinical outcome, particularly the need for systemic treatment, in patients with stage IB MF. Methods: This is a retrospective cohort study of patients with stage IB MF who underwent peripheral blood TCR clonality analysis by PCR. The primary outcome of the study was time from diagnosis to initiation of systemic treatment. Secondary outcomes were: (1) time to progression to advanced-stage disease (stages IIB-IV) and (2) overall survival. Patients were censored at time of last clinical follow up. Log rank test was used to compare the survival distributions of the two groups; p value < 0.05 was considered significant. Results: From May 2014 to October 2019, 56 consecutive stage IB pts with > 6 months follow up were included in this analysis. Peripheral blood TCR clonality status was available in 42 patients: 18 pts had a positive TCR clone and 24 did not. Median follow up time was 36 months (range 8.5 – 198 months). At 3 years, 39% of patients with peripheral clone had progressed to systemic treatment versus 8% of those without a peripheral clone (log rank test, p-value = 0.003). For the secondary outcomes, at 3 years 17% of patients with peripheral clone had progressed to advanced stage versus 4% of those without (log rank test, p-value = 0.10); 5% of patients with peripheral clone had died versus 0% of those without (log rank test, p-value = 0.03). Conclusions: Detection of a predominant TCR clone by PCR in the peripheral blood is an important prognostic marker in the initial workup of MF, as its presence is highly correlated with subsequent progression to systemic treatment and death. If this finding is validated, it can be used to risk stratify and individualize therapy for MF patients.[Table: see text]

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