Combination chemotherapy and surgical adjuvant chemotherapy on MS-2 sarcoma and lung metastases in mice.
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Animals↗
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Changes of granulopoiesis during and after adjuvant chemotherapy of breast cancer.
Adjuvant chemotherapy allows a study of the effects of cytotoxic drugs on natural human haematopoiesis. We describe serial studies of granulopoiesis performed during and after intermittent adjuvant chemotherapy for breast cancer (adriamycin plus cyclophosphamide, given for six courses at monthly intervals). After drug administration, a sequential wave of depletion and regeneration through successive granulopoietic compartments was observed. With repeated chemotherapy, moderate neutropenia developed, and the blood CFU-C pool size became progressively reduced. After the sixth chemotherapeutic course, granulopoietic regeneration was delayed. Following discontinuation of chemotherapy, a long-lasting (greater than 200 d) reduction of the blood CFU-C pool size, together with neutropenia and reduction of marrow segmented neutrophils, was observed, suggesting a defect of granulopoiesis with persistent granulopoietic hypoplasia. In patients with expected long survival, residual bone marrow damage should be added to the list of potential late side effects of cytotoxic drug therapy.
Bone Marrow↗
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↗
Surgical adjuvant chemotherapy.
The evidence that the principles of surgical adjuvant chemotherapy developed in experimental animal systems also apply to a variety of neoplastic diseases in man has been clearly demonstrated. Micrometastatic disease can be eradicated with effective chemotherapy in several diseases. Prolongation of disease-free interval, if not cure, is now possible in diseases in which curative surgery alone or in combination with radiotherapy does not achieve these goals. The previously fatal childhood solid tumors--Wilms', Ewings' sarcoma, embryonal rhabdomyosarcoma--are curable in a high percentage of patients appropriately treated with combinations of surgery, radiotherapy, and chemotherapy. The prolongation of the disease-free interval in osteogenic sarcoma has permitted consideration of entirely new surgical approaches for this tumor in which radical amputation has traditionally been employed. The spectacular results achieved in the treatment of Stage II breast cancer may potentially save hundreds of thousands of lives in the coming decade. Clinically recognizable metastatic disease is rarely curable by any currently available treatment modality. The prolongation of disease-free intervals and production of cures when surgical adjuvant chemotherapy is employed may be partly explained by relatively more circulation, and thus drug delivery to each tumor cell, more favorable cellular kinetics, and a healthier and more immunocompetent host who is better able to withstand drug effects on normal tissues, and to participate in tumor destruction. Cures of certain patients with neoplastic diseases using surgical adjuvant chemotherapy has increased the incentive to learn more about new and old drugs and their effective use alone and in combination. Chemotherapy, in appropriate combinations with surgery, radiotherapy, and immunotherapy, may well be more efficacious in many clinical situations than the traditional use of single-modality treatment. The data presented in this paper relate solid evidence that the possibility of cure in a variety of neoplastic diseases is real.
Adult↗
A preliminary report of a pilot trial in adjuvant chemotherapy of primary melanoma.
It is well known that level of skin invasion and tumor thickness are significant prognostic factors in the evolution of primary melanoma. The prognosis of primary melanoma Clark III to V skin invasion level and more than 1.5 mm thick confirms this statement. Even the prophylactic dissection of regional lymph nodes has not improved results. In an attempt to obtain better results in the treatment of primary melanomas, a pilot trial was carried out combining surgery and adjuvant chemotherapy. A group of 21 patients with Clark III, IV and V level primary melanoma who underwent adjuvant polychemotherapy (velba + dactinomycin + procarbazine) for 1 year after surgery showed a very low incidence of recurrences (5%) after 24 months of observation. The historical control group, with the same level of tumor skin invasion, treated only surgically had in the same follow-up period a recurrence rate of 65%. This difference was statistically significant (p less than 0.01). All patients who received adjuvant chemotherapy survived 2 years whereas survival was 77% (p less than 0.05) in the surgical historical control group. Favorable results with the same protocol of adjuvant chemotherapy were not obtained in the group of 16 patients with stage II melanoma when compared with primary tumors. However, 4 recurrences were observed after 12 months of observation; toxic side effects of adjuvant chemotherapy were mild and tolerable. Considering the insufficient number of clinical trials with adjuvant chemotherapy, as well as sometimes controversial results, further randomized clinical studies are needed to establish the actual value of this conbined method in the treatment of primary melanoma with a high risk of dissemination.
Antineoplastic Agents↗
Adjuvant chemotherapy for breast carcinoma: psychosocial implications.
Fifty women receiving adjuvant chemotherapy after surgery for Stage II breast carcinoma were interviewed in an effort to describe the psychosocial effect of the treatment. Perceptions of emotional distress and behavioral disruption were rated in five areas, yielding a rating of overall level of disruption and distress. Results showed that all women experienced adverse changes while receiving adjuvant treatments. Of the 50 women, 88% described a decrease in activities related to the effects of adjuvant chemotherapy; 54% reported an increased financial burden; and 41% claimed that their family and/or sexual life had been adversely affected. Despite these adverse changes, 74% of these patients "would definitely" recommend the treatment to friends in a similar situation. Results from this preliminary study may provide useful information to potential participants in adjuvant trials and to the physicians who conduct such trials.
Activities of Daily Living↗
Adjuvant chemotherapy: theoretical considerations and model studies.
Comparison of response of experimental tumors to adjuvant chemotherapy for minimal disease with the response of solid large tumors to similar drug regimens has indicated that for many tumors the small microscopic foci are more responsive. There are, however, a number of model tumors that respond far less to chemotherapy when applied to minimal disease than when applied to large tumors. The response of these tumors to adjuvant treatment shows similarities with the clinically observed response. The data do not support the hypothesis that the success of a drug combination given as adjuvant chemotherapy may be predicted from the success of the same treatment when applied for manifest disease.
Animals↗
Identifying gene expression signatures for risk stratification of postoperative adjuvant chemotherapy in colorectal cancer.
Clinical risk stratification for postoperative recurrence in patients with pathological stage II (pStage II) colorectal cancer (CRC) is essential for guiding the use of postoperative adjuvant chemotherapy (ACT). In this study, we identified novel prognostic gene expression biomarkers in patients with pStage II CRC and developed a new risk stratification framework for ACT decision-making. First, genome-wide biomarker discovery was conducted to identify prognostic gene expression biomarkers associated with recurrence risk in pStage II CRC. This analysis identified 10 differentially expressed genes as potential biomarkers for recurrence. The efficacy of these biomarkers was then tested using 188 clinical surgical specimens obtained from patients with pStage II CRC. A predictive panel was developed using qRT-PCR and used to assess 93 clinical specimens with an area under the curve (AUC) of 0.82, and its performance was further validated in an independent cohort (n = 95). By incorporating key clinicopathological features, a Gene expression-based Prediction of Recurrence in pStage II CRC (GPRSC) signature was developed, which robustly predicted postoperative recurrence (AUC: 0.80). Finally, combining the GPRSC signature, microsatellite instability status, and conventional criteria, we developed a novel risk stratification system for postoperative ACT decision-making in pStage II CRC. Overall, we identified novel gene expression biomarkers and developed a prognostic signature that informs clinical decision-making regarding postoperative ACT in patients with pStage II CRC.
Humans↗
Ovarian function in patients receiving adjuvant chemotherapy for breast cancer.
Plasma oestradiol-plus-oestron (E2 + E1), follicle-stimulating hormone (F.S.H.), luteinising hormone (L.H.), androstenedione (A2), and dehydroepiandrosterone sulphate (D.S.) were measured in 33 breast-cancer patients before and after adjuvant chemotherapy. Before treatment the plasma E2 + E1, A2, and D.S. levels were significantly higher and the L.H. and F.S.H. lower in the 16 premenopausal patients than in the 17 postmenopausal patients. After 6 mo of adjuvant chemotherapy the premenopausal patients, 11 of whom had become amenorrhoeic, showed striking reductions in plasma E2 + E1 and A2 and elevations in plasma L.H. and F.S.H. Further changes were evident after 12 mo of treatment. Plasma-A2 fell after chemotherapy in the postmenopausal group; the other hormones were unchanged. The beneficial effects of adjuvant chemotherapy for breast cancer may result, in part, from suppression of ovarian function.
Adult↗
[Adjuvant chemotherapy of the colonic and rectal carcinoma: concepts and uptodate results].
The aim of adjuvant chemotherapy is the destruction of micrometastases after surgical removal of a malignant tumor. This treatment modality is gaining in importance in the light of experimental data and lcinical success in pediatric tumors. Results of ongoing studies in colo-rectal cancer show a marginal effect of prophylactic treatment with 5-fluorouracil. The treatment benefits in trials with historical controls are much greater than in studies with simultaneous controls. Use of historical controls is therefore of doubtful value. Ongoing trials use the combination of 5-fluorouracil and methyl-CCNU, which has been shown to double the remission rate in advanced gastrointestinal cancer. Adjuvant chemotherapy of colo-rectal cancer is still experimental and justified only in the framework of clinical trials.
Animals↗
[Effectiveness of adjuvant chemotherapy in ovarian carcinoma].
A report is given about the efficiency of the so called adjuvant chemotherapy in 26 cases (26 patients suffering from ovarian cancer in the stage T1M0N0) in a time of 10 years (1968-1977).--After the primary operation-therapy, a part of the patients (9) got the cytostatic drugs Trenimon or Cyclophosphamid. The patients of the control group got nothing. The survival times of both groups showed no significant distinctions. -- The results show that the adjuvant chemotherapy in cases of ovarian cancers in stage T1M0N0 can not be recommended because there are too many side effects of the these cytostatic drugs.
Adult↗
Adjuvant chemotherapy and immunotherapy in high risk patients with melanoma.
Thirty-one patients with Stage II cutaneous melanoma received adjuvant chemotherapy or immunotherapy after radical excision of the primary and regional lymph nodes. Vaccinations with bacille Calmette Guérin produced minimal systemic reactions and was better tolerated by the patients than was chemotherapy. A higher survival rate and disease-free interval were noted in patients treated with bacille Calmette Guérin than those receving dimethyl Triazeno-imidazole carboximide. These results suggest that adjuvant chemotherapy with dimethyl Triazenoimidazole carboximide alone is not beneficial in the treatment of high risk patients with melanoma. In this study, adjuvant bacille Calmette Guérin therapy appears to be more advantageous than does chemotherapy.
Adult↗
Acute skin reactions in postoperative breast cancer patients receiving radiotherapy plus adjuvant chemotherapy.
A group of 26 patients with operable carcinoma of the breast received postoperative radiotherapy plus adjuvant chemotherapy. Acute skin reactions were studied by clinical observation. There was a statistically significant difference (P less than .01) in the acute skin reactions in the chest wall area in those who received chemotherapy (81%) compared to the controls who received only radiotherapy (33%). Acute skin reactions began at the completion of postoperative radiotherapy and reached maximum severity 1-2 weeks later. They usually subsided after 4-6 weeks. No skin reactions were observed in the parasternal, supraclavicular fossa, or axillary regions. On the basis of these findings, postoperative radiotherapy combined with adjuvant chemotherapy is probably beneficial.
Breast Neoplasms↗
A multicenter phase II trial of ramucirumab plus irinotecan for early recurrence of gastric cancer during or after adjuvant chemotherapy with docetaxel plus S-1 therapy: the RAMIEL trial (OGSG1901).
BACKGROUND: There is currently no established chemotherapy regimen for early recurrence of pathological stage III gastric cancer (GC) following adjuvant chemotherapy with docetaxel plus S-1 (DS) after D2 gastrectomy. We aimed to evaluate the efficacy and safety of ramucirumab plus irinotecan in patients with GC who experienced early recurrence during or within 6 months after DS adjuvant chemotherapy. METHODS: This prospective, open-label, multicenter phase II trial enrolled eligible patients treated at 25 centers of the Osaka Gastrointestinal Cancer Chemotherapy Study Group in Japan. Patients received ramucirumab (8 mg/kg) and irinotecan (150 mg/m2) every 2 weeks. The primary endpoint was overall survival (OS), and secondary endpoints included progression-free survival (PFS), objective response rate (ORR), and safety. The sample size was set at 40 based on a threshold median OS of 7 months and an expected median OS of 11 months, with a one-sided alpha error of 0.05 and a power of 0.80. RESULTS: Between November 2019 and July 2023, 43 patients were enrolled, and 39 were included in the analysis after excluding three ineligible patients and one who did not initiate protocol treatment. The median OS was 15.9 months (95% CI: 8.8-42.0; p = 0.003). The median PFS was 5.5 months (95% CI: 3.9-8.1), and the ORR was 38.5%. Grade  ≥ 3 adverse events, including neutropenia (25.6%) and hypertension (25.6%), were observed in more than 20% of patients. CONCLUSION: Ramucirumab plus irinotecan demonstrated promising efficacy and manageable toxicity in patients with early recurrence of GC following adjuvant DS therapy. TRIAL REGISTRATION: This study was prospectively registered in the Japan Registry of Clinical Trials (jRCTs05119071, October 6, 2019, https://jrct.niph.go.jp/latest-detail/jRCTs051190071 ).
Docetaxel↗
Adjuvant chemotherapy for bladder cancer with doxorubicin hydrochloride and cyclophosphamide: preliminary report.
We describe 25 patients with bladder cancer who received adjuvant chemotherapy with doxorubicin hydrochloride and cyclophosphamide after radical cystectomy. Two patients had stage A disease, 3 had stage B, 3 had stage C and 17 had stage D. The 2 patients with stage A tumors have been free of disease for 12 and 15 months, respectively, and the 3 patients with stage B tumors have been free of disease for an average of 25 months. Of the 3 patients with stage C tumors 2 have been free of disease for an average of 34.5 months. Of the 17 patients with stage D tumors 10 have been free of disease for an average of 1 year (59 per cent). These preliminary results seem to indicate the value of adjuvant chemotherapy with doxorubicin hydrochloride and cyclophosphamide in cases of bladder cancer.
Cyclophosphamide↗
Hepatic toxicity of adjuvant chemotherapy for carcinoma of the breast.
Four patients developed abnormal liver function tests and focal defects on liver scan while receiving cyclophosphamide, methotrexate and 5-fluorouracil as adjuvant chemotherapy following mastectomy for breast cancer. Liver biopsies showed severe focal inflammation. The biopsy findings and the subsequent clinical course of the patients strongly suggest that these abnormalities were due to hepatic toxicity of the chemotherapy and not metastic breast cancer. A review of serial liver function tests performed on 24 patients in that chemotherapy program revealed that four out of eight patients with elevated alkaline phosphatase prior to therapy developed early metastatic cancer. Elevated alkaline phosphatase occurring during chemotherapy on the other hand was quite common but more likely due to hepatic toxicity of the drugs. The development of abnormal liver function tests even in association with focal defects on liver scan is not sufficient to diagnose metastatic breast cancer in patients receiving adjuvant chemotherapy.
Adult↗
Adjuvant chemotherapy for breast cancer.
Prolonged chemotherapy has been used as an adjuvant to mastectomy in women with involved axillary nodes, in an attempt to ablate or suppress subclinical, micrometastatic disease. The preliminary results and surrounding controversies are reviewed. It is concluded that at this time there is a decreased relapse rate but no increase in survival, and it is in this light that adjuvant chemotherapy cannot be endorsed outside of well-conducted clinical trials.
Antineoplastic Agents↗
Surgical adjuvant chemotherapy: results with one short course with cyclophosphamide after mastectomy for breast cancer.
One single six-day course with cyclophosphamide (total dose 30 mg/kg) was given immediately after mastectomy to 507 breast cancer patients, with 519 randomized controls receiving no adjuvant chemotherapy. The control group now has 234 recurrences and 196 deaths, and the treatment group 175 recurrences and 146 deaths. The differences of 59 recurrences and 50 deaths in favour of the treatment group are significant with p values less than 0.001 and less than 0.01 respectively. The differences in recurrence rates increased gradually, reached 10.71% four years after mastectomy (p less than 0.001), and remained at the same level for another 6 years. The differences in death rates increased until 6 years after mastectomy, and was 10.48% after 10 years. With this pattern, the mechanism is probably not a delay in onset of clinical recurrences, but a definite reduction of recurrence rates due to tumoricidal chemotherapy. Prognostic factors or menstrual state had apparently no influence on the effect of this type of adjuvant chemotherapy. Side effects were of short duration and very moderate. Since there was a good effect in the prognostically most favourable groups of patients, treatment of such cases seems therefore also justified. The same chemotherapy course given 3 weeks after mastectomy seemed without effect.
Adult↗