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PubMed2025

MammaPrint predicts chemotherapy benefit in HR+HER2- early breast cancer: FLEX Registry real-world data.

BACKGROUND: Gene expression assays help personalize adjuvant chemotherapy decisions for hormone receptor-positive, HER2-negative (HR+HER2-) early breast cancer (EBC). The 70-gene risk of distant-recurrence signature, MammaPrint, demonstrated clinical utility in guiding chemotherapy de-escalation in genomically low risk patients in the MINDACT trial. This study evaluates MammaPrint as a continuous predictor of chemotherapy benefit in HR+HER2- EBC using real-world data (RWD) from the FLEX Registry. METHODS: The study evaluated 1002 patients treated with endocrine therapy (ET) only or ET with chemotherapy (ET+CT) enrolled in FLEX (NCT03053193) with 5-year median follow-up. Propensity-score matching balanced treatment groups by menopausal status, T-stage, and nodal status. The primary endpoint was distant recurrence-free interval (DRFI). Regression and Cox proportional hazards models assessed chemotherapy benefit across MammaPrint Index (MPI) risk. RESULTS: Most patients were postmenopausal (70.1%), node-negative (70.0%), and had grade 2 tumors (51.2%). The regression models showed that MPI strongly predicted 5-year DRFI in ET only (R2 = 0.99, P < .001) and ET + CT (R2 = 0.90, P < .001) groups, corresponding to an average absolute chemotherapy benefit of 5.6% in High 1 and 10.9% in High 2. Minimal improvement in DRFI with chemotherapy was observed for Low (1.7%) and UltraLow (<1.0%) risk groups. A multivariate Cox model with an MPI-by-treatment interaction term demonstrated that increasing MPI risk was associated with greater chemotherapy benefit on DRFI (HR = 0.15, P = .047). Chemotherapy benefit was significantly associated with premenopausal status, but not age, T-stage, nodal status, or grade. CONCLUSIONS: These RWD from the FLEX Registry demonstrate that MPI is predictive of both DRFI prognosis and chemotherapy benefit in HR+HER2- EBC. (NCT03053193).

Adult↗

PubMed2026

H&E to recurrence score: A step forward, but not yet a substitute for genomic testing.

Shamai and colleagues developed a multimodal deep-learning model that predicts Oncotype DX recurrence scores from routine H&E slides and clinicopathological variables in hormone receptor‑positive, HER2‑negative early breast cancer. Validated across the TAILORx trial and six external cohorts (over 5000 patients), the model achieved an AUC of 0.898 for identifying recurrence score ≥26 and recapitulated genomic assay patterns of chemotherapy benefit. Notably, 31% of clinically high-risk postmenopausal women were downgraded to low risk by AI, suggesting potential to reduce overtreatment. However, several limitations preclude immediate clinical substitution for genomic testing. First, intratumoural heterogeneity leads to discordant predictions with unclear management guidance. Second, the model's chemotherapy benefit estimates rely on TAILORx's age-based menopausal surrogates, which may not reflect real-world hormonal status or LHRH agonist use. Third, predictive value in node-positive disease remains untested in randomised datasets such as RxPONDER. Additionally, calibration uncertainty near risk thresholds and global scalability issues (including IHC requirements and digital pathology infrastructure) persist. While this represents a landmark step toward democratising precision oncology, the AI tool should currently serve as a complementary decision aid, with genomic testing remaining the gold standard for intermediate, borderline, or discordant cases.

Breast cancer↗

PubMed2026

Development and Validation of a Multimodal Clinical, Pathologic, and Genomic Model for Breast Cancer Recurrence.

PURPOSE: To develop and validate a multimodal recurrence-risk model integrating histology, genomic testing, and clinical variables. METHODS: We developed AI-Path, a whole-slide image biomarker for recurrence prediction trained in CALGB 9344, and validated it in three independent cohorts: TAILORx, a multi-site Chicago cohort, and the MDX-BRCA cohort. We then integrated AI-Path with Oncotype DX Recurrence Score (RS), tumor size, and nodal status into a Cox model, PathClinRS, fit using 60% of cases from TAILORx, with the remaining 40% held out for validation. The primary end point was distant recurrence-free interval. Performance was assessed using Harrell's concordance index (C-index) and Kaplan-Meier analyses. RESULTS: A total of 12,418 patients were included. In TAILORx, AI-Path outperformed RS for distant recurrence (C-index, 0.682 vs 0.647; P = .038), driven by superior prediction of late recurrence (0.656 vs 0.567; P < .001). In node-negative disease, PathClinRS outperformed RSClin in the TAILORx fitting (0.72 vs 0.70; P = .016) and validation sets (0.74 vs 0.70; P = .004). In node-positive disease, PathClinRS outperformed RSClinN+ in Chicago (0.94 vs 0.74; P < .001) and MDX-BRCA (0.71 vs 0.66; P = .004) cohorts. Compared with NATALEE eligibility, PathClinRS identified nearly twice as many high-risk node-negative patients while maintaining a comparable 10-year distant recurrence risk (16.7% vs 16.6% per NATALEE eligibility in TAILORx fitting; 21.0% vs 19.4% in TAILORx validation). PathClinRS identified 68% of intermediate risk premenopausal patients as low-risk with no evidence of chemotherapy benefit, compared to only 36% identified as low risk by standard clinicopathologic criteria. CONCLUSION: Digital histopathology provides prognostic information complementary to genomic assays and has the potential to personalize therapy beyond existing clinicogenomic tools.

Journal Article↗

PubMed1979

Cancer chemotherapy in advanced malignant disease. A cost benefit analysis.

A cost benefit analysis of chemotherapy in unselected patients with advanced malignant disease originating in a defined population (250 000 inhabitants) demonstrated that the use of this therapy as the main treatment in hospitalised patients increased from a few per cent during 1973 to 60 per cent during 1977, corresponding to an increase in the cost of drugs from 10 000 to 200 000 dollars. At the same time the capacity for hospital care of patients with advanced malignancies increased from 317 to 488 patients without any enlargement of other resources. As more than 90 per cent of the medical budget consists of expenditures for salaries and localities, a cheaper medical care was obtained, but, above all, the survival rate and the quality of life for many patients was improved.

Adult↗

PubMed1978

[Long-term, complete remission in non-Hodgkin's lymphoma following high-dosage combination therapy with or without autologous bone marrow transplantation].

22 patients with malignant non-Hodgkin lymphoma resistant to conventional chemotherapy were treated with high-dose combination chemotherapy followed in the first 12 patients by infusion of their cryopreserved autologous bone marrow. The next 10 patients received chemotherapy alone. Four patients died shortly after chemotherapy. Four patients remain in unmaintained remission 40, 30, 20 and 8 months after treatment. Patients receiving cryopreserved marrow recovered leukocyte, granulocyte and platelet function significantly faster and had significantly fewer febrile days than did controls. These findings demonstrate that high dose combination chemotherapy may benefit some patients unresponsive to conventional chemotherapy, and that cryopreserved bone marrow can speed hematopoetic recovery and be of clinical benefit to the patient.

Antineoplastic Agents↗

PubMed1979

Possible benefits of hyperthermia to chemotherapy.

The advantages of hyperthermia for chemotherapy are discussed in detail. These advantages are (a) synergy with chemotherapeutic drugs and also with ionizing radiation, (b) low host toxicity, (c) ease of control (heating precisions in the range of +/- 0.1 degrees C and specific definable localized areas), and (d) low resistance (chemotherapeutic resistance and hyperthermic resistance). The potential for hyperthermia and chemotherapy in the treatment of specific human cancers, both disseminated and solid tumors, are discussed with respect to current therapy and the possible benefit of hyperthermia treatment.

Antineoplastic Agents↗

PubMed1978

Prolonged complete remission following high dose chemotherapy of Burkitt's lymphoma in relapse.

Fourteen patients with American Burkitt's lymphoma resistant to conventional chemotherapy were treated with high-dose combination chemotherapy and intensive supportive care. Four patients died shortly after chemotherapy, 3 of an acute carditis. All ten remaining patients demonstrated tumor regression and 3 remain in prolonged complete unmaintained remission 29+, 19+, and 9+ months after treatment. These findings demonstrate that high-dose chemotherapy will benefit some patients with Burkitt's lymphoma unresponsive to conventional chemotherapy, but the medullary and extramedullary toxicity of this treatment strategy remains a formidable obstacle.

Adolescent↗

PubMed2026

Risk of Relapse and Efficacy of Adjuvant Chemotherapy in Localized Appendiceal Adenocarcinoma.

IMPORTANCE: Relapse risk and benefit of adjuvant chemotherapy after resection of appendiceal adenocarcinoma (AA) are uncertain. OBJECTIVE: To identify clinicopathologic and genomic factors associated with relapse and assess efficacy of adjuvant chemotherapy in localized AA. DESIGN, SETTING, AND PARTICIPANTS: This retrospective cohort study (January 2000 through February 2024; median follow-up, 62.6 months) used Kaplan-Meier and Cox proportional hazards modeling. It took place at the University of Texas MD (UT MD) Anderson Cancer Center with validation from Memorial Sloan Kettering Cancer Center (MSKCC). Participants included a complete localized cohort of 439 patients with stage I to III AA from UT MD Anderson, of whom 202 underwent surgery at UT MD Anderson and also included a validation cohort of 128 patients with stage II AA from MSKCC. EXPOSURES: Surgical resection with or without adjuvant chemotherapy. MAIN OUTCOMES AND MEASURES: Rate of recurrence, recurrence-free survival (RFS), and overall survival (OS). RESULTS: There were 439 patients with localized AA (median age, 56.5 [IQR, 22.2-83.7] years; 50% female and 50% male) managed at MD Anderson between January 2000 and February 2024. Of 202 MDA surgical patients, 19 (9.4%) had a relapse including 9 (6%) patients with stage II and 8 (19.5%) of patients stage III disease. Five-year OS was 95.7% without vs 77.2% with relapse (hazard ratio [HR], 5.50; 95% CI, 3.07-9.83; P < .001). Relative to goblet cell tumors, mucinous (HR, 5.60; 95% CI, 2.1-15; P < .001) and enteric-type (HR, 6.60; 95% CI, 2.9-15; P < .001) histologies were independently associated with relapse, as was pathologic T4 (HR, 3.30; 95% CI, 1.9-5.7; P < .001). Importantly, poor differentiation, perforation, lymphovascular invasion, and perineural invasion, known risk factors in colorectal cancer, were not significantly associated with relapse. For the complete localized cohort, adjuvant chemotherapy was not associated with improved RFS (univariate HR, 2.06; 95% CI, 1.36-3.13; P = .001 and multivariable HR, 0.98; 95% CI, 0.43-2.28; P = .90) or OS (univariate HR, 1.80; 95% CI, 1.0-3.2; P = .04 and multivariable HR, 0.71; 95% CI, 0.24-2.1; P = .53). TP53 mutation in goblet cell tumors (HR, 6.93; 95% CI, 1.50-31.00; P = .01) and GNAS mutation in nongoblet tumors (HR, 17.0; 95% CI, 3.09-93.3; P = .001) were associated with greater risk of relapse. CONCLUSIONS AND RELEVANCE: These results demonstrate that relapse after resection of localized AA is uncommon. Molecular profiling and histopathologic subtype refine risk. Adjuvant chemotherapy were not associated with benefit.

Journal Article↗

PubMed2026

Oncotype DX: Clinical Utility, Evidence, and Future Trends in Personalized Breast Cancer Management.

The Oncotype DX assay has revolutionized the management of early-stage, hormone receptor-positive, HER2-negative breast cancer. Developed in 2004, it quantifies 21 genes to generate a recurrence score that predicts distant recurrence risk and guides adjuvant chemotherapy. Multiple studies have validated its reliability and clinical utility in enabling more precise risk stratification and individualized treatment planning, thereby minimizing unnecessary chemotherapy exposure and improving patient outcomes. Leading oncology organizations such as the American Society of Clinical Oncology and National Comprehensive Cancer Network have incorporated it into their clinical guidelines. Beyond its well-established role in adjuvant chemotherapy decision-making, Oncotype DX is increasingly being investigated in broader clinical contexts, including lymph node-positive breast cancer, neoadjuvant therapy, radiotherapy, and ductal carcinoma in situ. Ongoing research and technological advancements, such as artificial intelligence-based predictive models and novel biomarker identification, hold significant promise for further enhancing its predictive accuracy and expanding its applications. This review synthesizes current evidence supporting the clinical utility of Oncotype DX, discusses evolving applications, and highlights future directions for integrating this genomic tool into precision oncology practice.

Humans↗

PubMed1979

Relapse rates following cessation of chemotherapy during complete remission of acute lymphocytic leukemia.

The therapeutic benefit of maintenance chemotherapy beyond three years for children with acute lymphocytic leukemia (ALL) in continuous complete remission was evaluated by the investigators of Childrens Cancer Study Group (CCSG). Two hundred and twenty leukemic children in first remission for three years or longer and who had received at least three years of continuous chemotherapy were eligible. One hundred and one patients were randomized to either continue chemotherapy for an additional three years or to discontinue therapy, and 119 patients nonrandomly continued or discontinued therapy. The patients had received a variety of chemotherapy regimens. The study period extended from April 1970 until December 1977, with a median follow-up time of 25 months. Relapses occurred in 15 randomized patients (15%). Randomized patients remaining on chemotherapy experienced a statistically significant lower relapse rate than patients randomized to discontinue therapy. Also among randomized patients, bone marrow relapse was significantly more frequent in males than in females. Considering the total patient group, age and white blood count at diagnosis had no significance in predicting relapse. Of relapse events in males, 21% were isolated testicular relapses, identifying the testicles as a major risk site in males completing three years of continuous complete remission. This study demonstrates that continuing chemotherapy beyond three years results in a significant prolongation of remission in males, although the eventual survival outcome for later discontinuance of therapy will require longer follow-up.

Bone Neoplasms↗

PubMed1978

Adjuvant chemotherapy in the management of primary malignant melanoma.

In a prospective randomized study, the effect of chemotherapy (either systemic or combined intraarterial and systemic) was studied in 117 patients undergoing a curative resection of Clark's level III, IV or V malignant melanoma. Systemic chemotherapy was started one month after surgery one week courses with an I.V. injection of Vinblastin 6 mg/m2, Thiotepa 6 mg/m2, Rufocromomycine 60 microgram/m2, Methotrexate 15 mg/m2 on day one with procarbazine 30 mg/m2 orally daily were given every other week for three months and later every four weeks. Intraarterial chemotherapy of DTIC 80 mg/kg day for ten days was given 28 days prior to surgery. 65 patients with limb malignant melanoma were treated either by surgery only (27 patients), or by systemic chemotherapy (23 patients) or by preoperative intraarterial chemotherapy and systemic chemotherapy (15 patients): 52 patients with non limb malignant melanoma were treated either by surgery only (28 patients) or by systemic chemotherapy (24 patients). We drew curves of disease free survival following surgery and studied the levelling off of the curves, 24 months after surgery 65% of the patients treated by surgery alone were alive and free of disease whereas 81% of the patients treated by surgery and chemotherapy were alive and free of disease (p less than 0.05) suggesting a possible benefit of adjuvant chemotherapy. Intraarterial preoperative chemotherapy has not proved of additional benefit to date.

Adult↗

PubMed2026

Role of ctDNA Tumor Fraction in Selecting Immunotherapy-Based Regimens in Advanced Non-Small Cell Lung Cancer.

PURPOSE: Immune checkpoint blockers (ICB) have transformed advanced non-small cell lung cancer (aNSCLC) treatment, but identifying patients who benefit from adding chemotherapy remains challenging, especially in PD-L1 ≥ 50%. PD-L1 is an imperfect biomarker, highlighting the need for better selection tools. EXPERIMENTAL DESIGN: Liquid biopsy (LBx) assessment was performed using hybrid capture-based next-generation sequencing of plasma cell-free DNA. LBx data, molecular profile, and clinicopathologic data were collected. The predictive and prognostic values of tumor fraction (TF) were assessed using a deidentified nationwide (US-based) NSCLC clinicogenomic database [Clinico-Genomic Database (CGDB)]. An independent cohort with aNSCLC from Gustave Roussy was used to validate the findings and to study the correlation of circulating tumor DNA (ctDNA) TF and total metabolic tumor volume and its molecular correlates. RESULTS: In the CGDB database (n = 965), elevated ctDNA TF was prognostic for worse outcomes on ICBs and, when ≥5%, predictive of benefit from ICB + chemotherapy [HR for real-world progression-free survival 0.58 (0.41-0.82); P = 0.002]. The 5% cutoff for TF was validated in an independent cohort from Gustave Roussy. In 283 patients with paired PET scans, ctDNA TF correlated with metabolic tumor volume (rho = 0.46; P < 0.001) and was influenced by TP53/RB1 mutations. CONCLUSIONS: ctDNA TF integrates disease burden and biology. Patients with high ctDNA TF derive greater benefit from chemoimmunotherapy, supporting its use as a biomarker to guide treatment intensification.

Humans↗

PubMed1975

Chemotherapy in advanced ovarian cancer.

Most patients with epithelial cancer of the ovary are not cured by surgery, since their cancer has spread beyond the ovaries. The majority of these patients are not suitable for postoperative irradiation therapy, since the residual tumors are too large to be effectively treated with irradiation or they have metastasized to areas that cannot be effectively irradiated. Approximately 50% of the patients with advanced ovarian cancer who are treated postoperatively with melphalan will benefit from this chemotherapy. Approximately 40% of the patients who do not respond to chemotherapy with melphalan will benefit from treatment with a combination of actinomycin D, 5-fluorouracil, and cyclophosphamide. A second-look operation after 12 or more cycles of chemotherapy is often helpful in planning future treatment of patients, and it may be curative in a few patients if all the remaining tumor can be excised.

Altretamine↗

PubMed1979

Intra-arterial chemotherapy of head and neck tumours.

The benefits and complications of regional chemotherapy in the treatment of head and neck tumours are discussed. Intra-arterial chemotherapy has been employed in 72 cases of preoperative, postoperative and palliative management. Cytostatic treatment consisted of combined Vincristine, bleomycin, methotrexate, and mitolactol administration by a Watkins-USCI or Sharp chronofusor. In cases of preoperative treatment the tumour regression was in the range of 50-80%. Tumours of the gingiva, parotid gland, maxilla and tonsil responded very well, tumours of the tongue less well to the treatment. The most dangerous complication is thrombosis of the common carotid artery; to avoid this complication the prothrombin index was reduced and kept at the 30-40% level.

Antineoplastic Agents↗

PubMed1979

[Current status in the treatment of breast cancer. II. Adjuvant chemotherapy, palliative polychemotherapy, chemoimmunotherapy--rating and results (author's transl)].

There is no well defined group of patients with primary breast cancer which benefits from combination chemotherapy as an adjuvant treatment, since, at present, the effect of this therapy in respect to the duration of disease-free interval, survival, and possible long-term side effects remain unknown. Therefore, controlled studies need to be initiated. Similarly, there seems to be no beneficial effect from unspecific immunotherapy. As far as combination chemotherapy in advanced breast cancer is concerned, we review on four different protocols which proved to be quite successful in our hands: adriamycine/cyclophosphamide (AC), cyclophosphamide/methotrexate/5-fluorouracil (CMF), CMF/vincristine/prednisone (CMFVP), and adriamycine/vincristine plus CMF plus Tamoxifen.

Antineoplastic Agents↗

PubMed1977

Combined modality therapy in malignant lymphomas.

The treatment of patients with non-Hodgkin's lymphomas remains controversial. The Rappaport classification system has established its clinical value in distinguishing relatively favorable disease (ie, nodular or follicular lymphoma) from relatively unfavorable disease (ie, diffuse lymphoma). Despite the problems of multiple histologies in a given patient posed by the existence of composite lymphomas and by a spectrum of nodularity in a given node, no newer classification has yet proved superior to the Rappaport system. The relative roles of radiotherapy and chemotherapy are reviewed. The primary role of radiation appears to be the control of detectable disease, when adequate doses and volumes are employed. The primary role of chemotherapy appears to be the eradication of microfoci of tumor. Randomized studies of combined modality approaches have produced no definitive evidence of benefit from adjuvant chemotherapy in stage I and II disease of unfavorable histology. The addition of adjuvant radiotherapy in stage III and IV disease of unfavorable histologic types appears to produce some improvement. Aggressive treatment regimes have yet to show any significant advantage over more conservative treatment in patients with favorable histologic types of stage IV extent. This paper emphasizes the need for expert hematopathologic interpretation in every study of non-Hodgkin's lymphoma.

Drug Therapy, Combination↗

PubMed2025

Applications and benefits of the British Society for Antimicrobial Chemotherapy Resistance Surveillance Project-legacy and future.

The BSAC Resistance Surveillance Project ran from 1999 to 2019, amassing an unrivalled collection of almost 100 000 bacterial isolates from bloodstream and lower respiratory tract infections in the UK and Ireland. It was initiated in response to increasing antimicrobial resistance and supplemented existing surveillance schemes, enhancing the understanding of resistance epidemiology by estimating species prevalence within collection groups together with levels of antibacterial resistance, presented in terms of MICs and percentage susceptibility for each species/antibiotic combination tested. Generated data were explored to monitor and identify factors shaping resistance trends, and to profile antibacterial resistance patterns in specific geographies, settings and patient populations. The release of data and/or bacterial isolates led to a rich repository of published peer-reviewed papers. Additionally, the promotion of the BSAC standardized susceptibility testing method resulted in greater uniformity of antimicrobial susceptibility testing in hospital microbiology laboratories. Over time, public health laboratories' surveillance systems became increasingly comprehensive, and the BSAC Project ceased in 2019. This invaluable collection is now housed in the University of Dundee, in collaboration with the University of St Andrews. We highlight the collection's unique timeliness, and how the BSAC Project contributed to key interventions for infection prevention and control, public health and antimicrobial stewardship. We demonstrate the utility and benefits of the Project outlining the collection's future applications as an important bioresource. It comprises well-defined bacterial isolates-many now sequenced-with MIC data and demographic information. This legacy is available to researchers via the Tayside Biorepository and custodian contacts.

Humans↗

PubMed1979

cis-Platinum combination chemotherapy of bladder cancer: an update.

The combination of cis-platinum (DDP), adriamycin, and 5-fluorouracil was evaluated in 44 patients with advanced urothelial cancer, 39 of whom were evaluable for response. There were 18 partial remissions (46.2%) and no complete responses. Remissions were clinically meaningful, but of short duration. Four patients had bulky pelvic disease that was made resectable by chemotherapy, but none of these patients remained disease-free. These results are not superior to that expected from DDP as a single agent. In addition, there appears to be little or no survival benefit associated with chemotherapy. DDP represents an advance in the treatment of bladder cancer, but additional active agents and innovative approaches are needed.

Adult↗